Robot surgical platform

ABSTRACT

A surgical implant planning computer is connectable to a fluoroscopy imager, a marker tracking camera, and a robot having a robot base coupled to a robot arm that is movable by motors relative to the robot base. Operations include performing a registration setup mode that determines occurrence of a first condition indicating the marker tracking camera can observe to track reflective markers that are on a fluoroscopy registration fixture of the fluoroscopy imager, and determines occurrence of a second condition indicating the marker tracking camera can observe to track dynamic reference base markers attached to the robot arm and/or an end-effector connected to the robot arm. While both of the first and second conditions occur, operations are allowed to be performed to obtain a first intra-operative fluoroscopic image of a patient along a first plane and to obtain a second intra-operative fluoroscopic image of the patient along a second plane that is orthogonal to the first plane.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/851,513 filed on Apr. 17, 2020 which is a continuation of U.S. patentapplication Ser. No. 16/037,212 filed on Jul. 17, 2018 which claimspriority under 35 U.S.C. 119(e) to U.S. Provisional Patent ApplicationSer. No. 62/535,591, filed Jul. 21, 2017, the content of which isincorporated by reference herein in its entirety for all purposes.

TECHNICAL FIELD

The present disclosure relates to medical devices, and moreparticularly, robotic surgical systems and related methods and devices.

BACKGROUND

Various medical procedures require the precise localization of athree-dimensional position of a surgical instrument within the body of apatient in order to effect optimized treatment. For example, somesurgical procedures to fuse vertebrae require that a surgeon drillmultiple holes into the bone structure at specific locations. To achievehigh levels of mechanical integrity in the fusing system, and to balancethe forces created in the bone structure, it is necessary that the holesare drilled precisely at desired locations. Vertebrae, like most bonestructures, have complex shapes made up of non-planar curved surfacesmaking precise and perpendicular drilling difficult. Conventionally, asurgeon manually holds and positions a drill guide tube by using aguidance system to overlay the drill tube's position onto a threedimensional image of the bone structure. This manual process is bothtedious and time consuming. The success of the surgery is largelydependent upon the dexterity of the surgeon who performs it.

Robot surgical platforms are being introduced that can assist surgeonswith positioning surgical tools and performing surgical procedureswithin a patient body. A robot surgical platform can include a robotthat is coupled to an end-effector element, and where the robot isconfigured to control movement and positioning of the end-effectorrelative to the body. The end-effector may be a surgical tool guidetube, such as a drill guide tube, or may be the surgical tool itself.

There is a need for a robot surgical platform that provides accuratelocalization of a three-dimensional position of a surgical tool relativeto the body in order to effect optimized treatment. Improvedlocalization accuracy can minimize human and robotic error whileallowing fast and efficient surgical process. The ability to performoperations on a patient with a robot surgical platform and computersoftware can enhance the overall surgical procedure and the resultsachieved for the patient.

SUMMARY

Some embodiments of the present disclosure are directed to a surgicalimplant planning computer that includes at least one network interface,a display device, at least one processor, and at least one memory. Theat least one network interface is connectable to a fluoroscopy imager, amarker tracking camera, and a robot having a robot base coupled to arobot arm that is movable by motors relative to the robot base. The atleast one memory stores program code that is executable by the at leastone processor to perform operations. The operations include performing aregistration setup mode that includes determining occurrence of a firstcondition indicating the marker tracking camera can observe to trackreflective markers that are on a fluoroscopy registration fixture of thefluoroscopy imager, and determining occurrence of a second conditionindicating the marker tracking camera can observe to track dynamicreference base markers attached to the robot arm and/or an end-effectorconnected to the robot arm. While both of the first and secondconditions are determined to continue to occur, the operations areallowed to be performed to obtain a first intra-operative fluoroscopicimage of a patient along a first plane and to obtain a secondintra-operative fluoroscopic image of the patient along a second planethat is orthogonal to the first plane.

Corresponding methods and computer program products are disclosed.

Still other surgical implant landing computers, methods, and computerprogram products according to embodiments of the inventive subjectmatter will be or become apparent to one with skill in the art uponreview of the following drawings and detailed description. It isintended that all such surgical implant landing computers, methods, andcomputer program products be included within this description, be withinthe scope of the present inventive subject matter, and be protected bythe accompanying claims. Moreover, it is intended that all embodimentsdisclosed herein can be implemented separately or combined in any wayand/or combination.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the disclosure and are incorporated in a constitute apart of this application, illustrate certain non-limiting embodiments ofinventive concepts. In the drawings:

FIG. 1 illustrates a robotic system that includes a robotic base stationand a camera stand.

FIG. 2 illustrates components of a robotic base station.

FIG. 3 illustrates the monitor of the robotic base station.

FIG. 4 illustrates the control panel on the rear of the robotic basestation and the control panel functions.

FIG. 5 illustrates the connector panel located at the rear of therobotic base station.

FIG. 6 illustrates the 5-axis robotic arm.

FIG. 7 illustrates the lower arm.

FIG. 8 illustrates the upper part of the vertical column.

FIG. 9 illustrates the camera stand.

FIG. 10 illustrates the rear view of the camera stand showing alignmentbuttons.

FIG. 11 illustrates isometric and top views of the end-effector.

FIG. 12 illustrates the detent mechanism on the instrument sensing ring.

FIG. 13 illustrates a scalpel used through the guide tube.

FIG. 14 illustrates the trajectory of the outer cannula.

FIG. 15 illustrates one technique for dilating tissue with the devices.FIG. 15(a) illustrates how the outer cannula is positioned above theincision. FIG. 15(b) illustrates how the cannulas is placed into theguide tube such that it rests on skin. FIG. 15(c) illustrates how thefirst inner cannula is inserted into the incision. FIG. 15(d)illustrates how the second inner cannula is then inserted into theincision. FIG. 15(e) illustrates how the outer cannula is then insertedinto the incision. FIG. 15(f) illustrates both inner cannulas then beingremoved and lowering the guide tube until it sits within the outercannula.

FIG. 16 illustrate some embodiments of the navigated survivalinstruments.

FIG. 17 illustrates the array.

FIG. 18 illustrates the verification probe.

FIG. 19 illustrates the patient attachment instruments.

FIG. 20 illustrates tightening bone clamp using clamp driver.

FIG. 21 illustrates the guide post and the quattro spike.

FIG. 22 illustrates one method for inserting a low profile quattro spikeinto rigid bony anatomy. FIG. 22(a) illustrates positioning a quattrospike over a guide post. FIG. 22(b) illustrates attaching an impactioncap. FIG. 22(c) illustrates inserting an assembly into a rigid anatomy.FIG. 22(d) illustrates removing a cap and guide pose.

FIG. 23 illustrates inserting a rod attachment instrument including aset screw, to attach to the existing spinal rod.

FIG. 24 illustrates a surveillance marker.

FIG. 25 illustrates a use of a surveillance marker with a bone clamp.

FIG. 26 illustrates a dynamic reference base.

FIG. 27 illustrates an intra-op registration fixture and pivoting arm.

FIG. 28 illustrates a Fluoroscopy Registration Fixture.

FIG. 29 illustrates an end effector motion when moving from onetrajectory to the next, wherein 1, 2, and 3 are automatic movements; 4is manual and optional.

FIG. 30 illustrates a power button, line power indicator and batteryindicator.

FIG. 31 illustrates a camera stand undocking. FIG. 31(a) illustratespulling up on the release handle located on a camera stand. FIG. 31(b)illustrates clearing the legs of a camera stand legs automaticallyreleasing and moving outward.

FIG. 32 illustrates the connection of a camera to a connector panel on abase station.

FIG. 33 illustrates a camera positioning.

FIG. 34 illustrates pressing a laser button to align the camera.

FIG. 35 illustrates a system with a sterile drape.

FIG. 36 illustrates a foot pedal cable connection.

FIG. 37 illustrates buttons which are illuminated when stabilizersengage and stabilizers disengage.

FIG. 38 illustrates the robotic arm interface plate for connection tothe end effector.

FIG. 39 illustrates opening brackets on an end effector and place theend effector on the interface plate by aligning the V grooves andalignment spheres.

FIG. 40 illustrates squeezing brackets on both sides of an end effectorand press the handle down to lock into place.

FIG. 41 illustrates a correct and incorrect positioning of a handle downto lock into place.

FIG. 42 illustrates a removal of the end effector.

FIG. 43 illustrates inserting an instrument shaft into an array sleeve.

FIG. 44 illustrates a surgical instrument assembly.

FIG. 45 illustrates attaching a quick connect handle on the proximal endof a shaft of the surgical instrument assembly.

FIG. 46 illustrates attaching a reflective marker to one of a pluralityof marker posts of the instrument assembly. FIG. 46(a) illustrateslowering the reflective marker onto a marker post. FIG. 46(b)illustrates a marker fully seated on the post.

FIG. 47 illustrates a login screen displayed on a monitor.

FIG. 48 illustrates a case management screen displayed on a monitor.

FIG. 49 illustrates a CONFIGURE tab used to display procedure types.

FIG. 50 illustrates a PREPLAN tab displayed on the monitor to select theimplant system, desired vertebral level and orientation.

FIG. 51 illustrates a VERIFY tab displaying navigation details includingvisibility, location and verification status of the instruments selectedon the PREPLAN tab.

FIG. 52 illustrates a pop-up screen appearing on the VERIFY tab toindicate the verification progress.

FIG. 53 illustrates verification divots located on the end effector.

FIG. 54 illustrates a green circle indicating a successful verification.

FIG. 55 illustrates a red crossed circle indicating a failedverification.

FIG. 56 illustrates securing a Dynamic Reference Base to a patientattachment instrument.

FIG. 57 illustrates using a clamp driver to a Dynamic Reference Base.

FIG. 58 illustrates the placement of a Dynamic Reference Base and asurveillance marker.

FIG. 59 illustrates a quattro spike.

FIG. 60 illustrates a quattro spike removal tool.

FIG. 61 illustrates removing a quattro spike with a removal tool.

FIG. 62 illustrates attaching a registration fixture to a pivoting arm.

FIG. 63 illustrates a registration fixture connecting to a patientattachment instrument.

FIG. 64 illustrates a registered fiducial.

FIG. 65 illustrates a PLAN tab allowing a user to plan all screwtrajectories on a patient image.

FIG. 66 illustrates a NAVIGATE tab allowing a user to visualize anavigated instrument trajectory and a planned trajectory with respect topatient anatomy.

FIG. 67 illustrates a PLAN tab allowing a user to plan all screwtrajectories on a patient image.

FIG. 68 illustrates the first screen highlighting the three steps tocomplete before the fluoroscopy images can be taken to register thepre-operative CT image.

FIG. 69 illustrates a Fluoroscopy Registration Fixture attached to imageintensifier.

FIG. 70 illustrates a lateral image within the NAVIGATE tab.

FIG. 71 illustrates selecting the desired level.

FIG. 72 illustrates a successful registration with a check mark beingshown next to the active level.

FIG. 73 illustrates how the real-time instrument/implant trajectory isdisplayed on the patient images along with the planned screw, allowingthe user to confirm the desired trajectory.

FIG. 74 illustrates a lateral image within the NAVIGATE tab.

FIG. 75 illustrates the PLAN tab allowing the user to plan all screwtrajectories on the patient image.

FIG. 76 illustrates the NAVIGATE tab allowing the user to visualize thenavigated instrument trajectory and the planned trajectory with respectto patient anatomy.

FIG. 77 illustrates how the robotic computer system may be used fornavigation without the robotic arm and end effector.

FIG. 78 illustrates how the robotic computer system may be used fortrajectory guidance using the robotic arm without navigated instruments.

FIG. 79 illustrates a block diagram of electronic components of a robotportion of a robot surgical platform which is configured according toembodiments.

FIG. 80 illustrates a block diagram of a surgical system that includes asurgical implant planning computer which may be separate from andoperationally connected to the robot or incorporated therein.

FIGS. 81-87 are flowcharts of operations that may be performed by asurgical implant planning computer which is configured according toembodiments.

DETAILED DESCRIPTION

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the present disclosure. Variousmodifications to the illustrated embodiments will be readily apparent tothose skilled in the art, and the principles herein can be applied toother embodiments and applications without departing from embodiments ofthe present disclosure. Thus, the embodiments are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theembodiments. Skilled artisans will recognize the examples providedherein have many useful alternatives and fall within the scope of theembodiments.

System Overview

The robotic computer system enables real-time surgical navigation usingradiological patient images and guides the trajectory of specializedsurgical instruments along a surgeon-specified path using a robotic arm.The system software reformats patient-specific CT images acquired beforesurgery, or fluoroscopic images acquired during surgery, and displaysthem on screen from a variety of views. Prior to operating, the surgeonmay then create, store, access, and simulate trajectories. Duringsurgery, the system guides the instruments to follow the trajectoryspecified by the user, and tracks the position of surgical instrumentsin or on the patient anatomy and continuously updates the instrumentposition on these images. The surgery is performed by the surgeon, usingthe specialized surgical instruments.

The software can also show how the actual position and path duringsurgery relate to the pre-surgical plan, and can help guide the surgeonalong the planned trajectory. While the surgeon's judgment remains theultimate authority, real-time positional and trajectory informationobtained through the robotic computer system can serve to validate thisjudgment. An example robotic computer system that could be used withembodiments herein is the ExcelsiusGPS™ by Globus Medical.

Device Description

The robotic computer system is a Robotic Positioning System thatincludes a computer controlled robotic arm, hardware, and software thatenables real time surgical navigation and robotic guidance usingradiological patient images (pre-operative CT, intra-operative CT andfluoroscopy), using a dynamic reference base and positioning camera. Thenavigation and guidance system determines the registration or mappingbetween the virtual patient (points on the patient images) and thephysical patient (corresponding points on the patient's anatomy). Oncethis registration is created, the software displays the relativeposition of a tracked instrument, including the end-effector of therobotic arm, on the patient images. This visualization can help guidethe surgeon's planning and approach. As an aid to visualization, thesurgeon can plan implant placement on the patient images prior tosurgery. The information of the plan coupled with the registrationprovides the necessary information to provide visual assistance to thesurgeon during free hand navigation or during automatic roboticalignment of the end-effector.

During surgery, the system tracks the position of GPS compatibleinstruments, including the end-effector of the robotic arm, in or on thepatient anatomy and continuously updates the instrument position onpatient images utilizing optical tracking. Standard non-navigatedmetallic instruments that fit through the guide tube at the selectedtrajectory may be used without navigation while the guide tube isstationary, for uses such as bone preparation (e.g. rongeurs, reamersetc.) or placing MIS implants (e.g. rod inserters, locking cap drivers)that are not related to screw placement. Navigation can also beperformed without guidance. System software is responsible for allmotion control functions, navigation functions, data storage, networkconnectivity, user management, case management, and safety functions.robotic computer system surgical instruments are non-sterile, re-usableinstruments that can be operated manually or with the use of thepositioning system.

Robotic computer system instruments include registration instruments,patient reference instruments, surgical instruments, and end-effectors.Registration instruments incorporate arrays of reflective markers, andare used to track patient anatomy and surgical instruments and implants;components include the verification probe, surveillance marker, surgicalinstrument arrays, intra-op CT registration fixture, fluoroscopyregistration fixture, and dynamic reference base (DRB). Patientreference instruments are either clamped or driven into any appropriaterigid anatomy that is considered safe and provides a point of rigidfixation for the DRB. Surgical instruments are used to prepare theimplant site or implant the device, and include awls, drills, drivers,taps, and probes. End-effectors can be wirelessly powered guide tubesthat attach to the distal end of the robotic arm and provide a rigidstructure for insertion of surgical instruments.

Indications for Use

The robotic computer system is intended for use as an aid for preciselylocating anatomical structures and for the spatial positioning andorientation of instrument holders or tool guides to be used by surgeonsfor navigating or guiding standard surgical instruments in open orpercutaneous procedures. The system is indicated for any medicalcondition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure, such as the skull,a long bone, or vertebra can be identified relative to a CT-based model,fluoroscopy images, or digitized landmarks of the anatomy.

Contraindications

Medical conditions which contraindicate the use of the robotic computersystem and its associated applications include any medical conditionswhich may contraindicate the medical procedure itself.

Navigation Integrity

The robotic computer system has built-in precautions to supportnavigation integrity but additional steps should be taken to verify theaccuracy of the system during navigation. Specific steps include:

Ensure the stabilizers have been engaged prior to using the robotic arm.

Do not move the dynamic reference base after successful registration.

Use a surveillance marker with every procedure to further confirm theaccuracy of the images in relation to real-time patient anatomy.

If a surveillance marker alerts movement of patient relative to thedynamic reference base, perform a landmark check. If a landmark checkfails, re-register the patient.

Use a verified navigation instrument to perform an anatomical landmarkcheck prior to a procedure. If a landmark check fails, re-register thepatient.

Compliance with Standards

This product conforms to the requirements of council directive 93/42/EECconcerning medical devices, when it bears the CE Mark of Conformityshown below, shown at right.

This product conforms to the requirements of standards listed below whenit bears the following NRTL Certification Compliance Mark, shown atright.

Electric and electromagnetic testing have been performed in accordancewith the following applicable standards: ANSI/AAMI ES60601-1, CSAC22.2#60601-1, CISPR 11, IEC 60601-1 (including all nationaldeviations), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-9, IEC 60601-2-49(only portions of this standard are used to demonstrate compliance andproper operation of the robotic computer system when used with highfrequency surgical equipment such as a cauterizer), IEC 60825-1, IEC62304, IEC 62366.

HF Surgical Equipment

Based on the robotic computer system floating applied part (type BF) andthe safety testing performed, the system is compatible with the use ofHF surgical equipment with no restrictions on the conditions of use.

EMC Compliance

In accordance with IEC 60601-1-2:2014 Edition 3 and 4, MedicalElectrical Equipment needs special precautions regarding ElectroMagnetic Compatibility (EMC) and needs to be installed and put intoservice according to the EMC information provided in the tables below.Portable and mobile RF communications equipment can adversely affectelectrical medical equipment. The tables supply details about the levelof compliance and provide information about potential interactionsbetween devices. EMC Compliance tables from 3rd Edition are shown on thenext page with values adjusted for 4th Edition where appropriate.

The robotic computer system has an optional 802.11 g/b/n wireless routerand tablet option. When installed, this transmits RF power at 2.4 GHz(2.412-2.484 GHz) using DSSS or OFDM with DQPSK or QAM modulation.Maximum RF transmit power is 100 mW. Recommended separation distances

Separation distance according to frequency of transmitter (m) Rated 150kHz 80 MHz 800 MHz maximum to to to output power of 80 MHz 800 MHz 2.5GHz transmitter (W) d = 1, 2 √{square root over (P)} d = 1, 2 √{squareroot over (P)} d = 2, 3 √{square root over (P)} 0.01 0.3* 0.3* 0.3* 0.10.37 0.37 0.74 1 1.17 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33*30 cm is the minimum recommended separation distance even though thecalculation would yield a shorter distance. For transmitters rated at amaximum output power not listed above, the recommended separationdistance in meters (m) can be estimated using the equation applicable tothe frequency of the transmitter, where P is the maximum output powerrating of the transmitter in watts (W) according to the transmittermanufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance forthe higher frequency range applies. NOTE 2: These guidelines may notapply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.

Cybersecurity

The robotic computer system adheres to industry best practices and FDAguidance on cybersecurity in medical devices. This includes firewallprotection and additional protection against virus, malware, datacorruption, and unauthorized system access.

System Overview

The robotic computer system consists of four main components: RoboticBase Station (shown below), Camera Stand (shown below), Instruments, andSystem Software. FIG. 1 illustrates a robotic system that includes arobotic base station and a camera stand.

Robotic Base Station

The Robotic Base Station is the main control center for the roboticcomputer system and includes the components shown below. FIG. 2illustrates components of the robotic base station. The robotic basestation includes a vertical column 206 that supports an upper arm 200connected to a lower arm 202, with a bracelet and end effector 204connected to the lower arm 202. An information ring 220 on the verticalcolumn 206 is illuminated to provide information as described below. Amonitor 218 is connected to the vertical column 206. The robotic basestation also includes a tablet compartment 216, a control panel 208, aconnector panel 210, stabilizers 212, and rolling casters 214.

Monitor

The monitor allows the surgeon to plan the surgery and visualizeanatomical structures, instruments, and implants in real time. It is ahigh resolution, flat panel touch screen liquid crystal display (LCD)located on the vertical column. The monitor can be adjusted to thedesired location with two hands. An external mouse is available foroptional use with the monitor. The mouse is not intended for use withinthe sterile field. FIG. 3 illustrates the monitor of the robotic basestation.

Tablet

An optional wireless tablet is available for use as a second touchscreenmonitor for operative planning and software control. The main monitorremains active at all times during use. The user can lockout tablet useif desired. The tablet compartment is used to store the tablet. Thetablet is not intended for use within the sterile field.

Control Panel

The control panel is located at the rear of the Robotic Base Station.This panel is used to display and control system power and generalpositioning functions. FIG. 4 illustrates the control panel on the rearof the Robotic Base Station and the control panel functions. The controlpanel includes: emergency stop button 400, stabilizers disengage button402, a left position button 404, a straight position button 406, a rightposition button 408, a vertical column up button 410, a vertical columndown button 412, a dock position button 414, a stabilizers engage button416, a battery status indicator 418, a power button 420, and a linepower indicator 422.

Control Panel Functions

Button Function To Use Emergency Removes power from Press down toactivate. To Stop motors and applies deactivate and re-power, twistbrake knob counterclockwise. Line Power Illuminates when system Press toturn ON/OFF Indicator is plugged into AC power outlet Power Powers theRobotic Press to turn ON/OFF Button Base Station ON/OFF. Illuminatedwhen ON. Battery Indicates level and Indicator state of charge All barsare illumi- nated when fully charged When operating on battery, numberof illuminated bars indicates percent of charge Bars progressivelyillumi- nate when charging Stabilizers Illuminates when system is Pressto disengage the stabi- Disengage free to move lizers to allow movementof the system Stabilizers Illuminates when system is Press to engage thestabilizers, Engage secured to floor to lock the system in place LeftMoves upper arm forward Press and hold button. Position and lower arm ata 90° Operator may release button angle to the left prior to finalposition and arm will stop in current position. Right Moves upper armforward Position and lower arm at a 90° angle to the right. StraightMoves upper and lower Stop in Position arm forward current position DockMoves upper and lower Position arm to rest over the cabinet VerticalMoves vertical column Press and hold button. Column Up up Operatorshould release button once the desired height is reached. Vertical Movesvertical column Column down Down

Connector Panel

The connector panel is located at the rear of the Robotic Base Station.This panel contains external connection ports for various devices. FIG.5 illustrates the connector panel located at the rear of the RoboticBase Station. The connector panel includes: an equipotential terminal562, a foot pedal connector 563, a camera connector port 564, an HDMIconnector 565, an ethernet connector 566, and dual USB 3.0 ports 567.

Connector Panel Functions

Item Function Equipotential Used to connect to other auxiliaryequipment; used Terminal by service personnel Foot Pedal Connects to thefoot pedal cable Connector Camera Connects to the camera stand cableConnector HDMI Connects to an external monitor Connector EthernetConnects to a network or intra-operative Connector imaging system forimage transfer USB Port 3.0 Connects to a USB device for image transferConnects to C-Arm via video capture supplied with the FluoroscopyRegistration Fixture

Casters and Stabilizers

The system consists of four casters with integrated stabilizers. Thestabilizers are used to immobilize the system to ensure that it does notmove during use.

Upper Arm, Lower Arm, and Vertical Column

The robotic arm, which consists of an upper and lower arm, is attachedto the vertical column of the robotic computer system Robotic BaseStation. This configuration allows for a wide range of motion.

The robotic computer system employs a state of the art drive controlsystem along with high performance servo drives to accurately positionand control the 5-axis robotic arm in an operating room environment.FIG. 6 illustrates the 5-axis robotic arm. The 5 axes of motion areidentified below.

Axis Travel Distance Vertical 670 ≥480 mm Shoulder 672 −150° to 180°Elbow 674 −150° to 150° Roll 676 −135° to 135° Pitch 678 −70° to 70°

Bracelet

The bracelet is located at the distal end of the lower arm. It is a loadsensing component that allows user guided positioning of the roboticarm.

To initiate motion, squeeze the bracelet ring with the thumb andforefinger on opposite sides. While squeezed, apply light force towardthe desired direction of motion. The robotic arm will move in thedesired direction. The arm moves manually in any direction or along atrajectory if a screw plan is active. FIG. 7 illustrates the lower armwhich includes a bracelet 700 and a bracelet ring 722.

Information Ring

The information ring is located on the upper part of the verticalcolumn. The information ring indicates the status of the roboticcomputer system. The information ring light blinks while the system isbooting up; a solid green light is displayed when the system is ready.Individual colors are used to indicate status, as shown in the tablebelow. FIG. 8 illustrates the upper part of the vertical column in whichincludes an information ring 800 that is limited to provide informationindications to a user.

Information Ring Color Indications

Color Description Red System is in an error state. Stop all tasks andresolve the issue immediately as it is either a safety issue or aserious problem with the system. Yellow System is in a state in whichuser intervention is required before a planned trajectory can beactivated. Green System is ready.

Camera Stand

The camera stand is mobile and adjusts in order to position the camerato view the operating field and optical markers. FIG. 9 illustrates thecamera stand. The camera stand includes: a camera 904; a camera laseralignment light 906; a positioning handle 908; a support arm 910; aheight adjustment handle 912; a locking handle 914; a docking handle916; a release handle 918; a cable holder 920; legs 922; and casters924. FIG. 10 illustrates the rear view of the camera stand showingalignment buttons. The camera stand further includes a handle tiltbutton 1020 and a laser button 1022.

Camera Stand Functions

Item Function Camera Used to detect the reflective markers and isattached to the top of the camera stand. For more information, pleaserefer to the NDI Passive Polaris Spectra User Guide. Positioning Used toadjust the camera position to ensure the Handle surgical field is inview. Handle Tilt Used to adjust the angle of the positioning handleButton with respect to the camera in the field of view. Laser ButtonTurns the camera laser alignment light on and off. The laser light isused for assistance in aligning the camera in the field of view. ArmProvides a large range of positions for the camera. Height AdjustmentAllows for adjustment of camera height. Handle Locking Handle Used tolock camera position. Docking Handle Used to collapse the legs fordocking the camera stand into the Robotic Base Station. Release HandleReleases the camera from the Robotic Base Station. Casters The camerastand contains four casters. The rear casters are lockable to preventthe camera stand from moving. Legs The camera stand legs swing inwardfor docking and outward when deployed. Cable Holder Provides storage forthe camera stand cable.

Cabling

The following cable characteristics are required for connecting toexternal devices: HDMI—Connecting to an external HDMI Monitor requires ashielded HDMI-Male to HDMI-Male cable.

Network—Connecting to a Hospital network can be done with an unshieldedCAT-5e Ethernet cable.

Electronic Components of Surgical Robot

FIG. 79 illustrates a block diagram of electronic components of a robot500 portion of a robot surgical platform which is configured accordingto embodiments. The robot 500 can include platform subsystem 502,computer subsystem 520, motion control subsystem 540, and trackingsubsystem 530. Platform subsystem 502 can include battery 506, powerdistribution module 504, platform network interface 512, and tabletcharging station 510. Computer subsystem 520 can include computer 522,display 524, and speaker 526. Motion control subsystem 540 can includedriver circuit 542, motors 550, 551, 552, 553, 554, stabilizers 555,556, 557, 558, end-effector 544, and controller 546 (e.g., one or moreprocessors and associated circuitry). Tracking subsystem 530 can includeposition sensor 532 and camera converter 534 which is connectable to amarker tracking camera 570, e.g., via the platform network interface512. Robot 500 can include a foot pedal 580 and tablet computer 590.

Input power is supplied to robot 500 via a power source 560 which may beprovided to power distribution module 504. Power distribution module 504receives input power and is configured to generate different powersupply voltages that are provided to other modules, components, andsubsystems of robot 500. Power distribution module 504 may be configuredto provide different voltage supplies to platform network interface 512,which may be provided to other components such as computer 520, display524, speaker 526, driver 542 to, for example, power motors 550, 551,552, 553, 554 and end-effector 544, ring 514, camera converter 534, andother components for robot 500 for example, fans for cooling the variouselectrical components.

Power distribution module 504 may also provide power to other componentssuch as tablet charging station 510 that may be located within a tabletdrawer. Tablet charging station 510 may be configured to communicatethrough a wired and/or wireless interface with tablet 590. Tablet 590may be used to display images and other information for use by surgeonsand other users consistent with various embodiments disclosed herein.

Power distribution module 504 may also be connected to battery 506,which serves as a temporary power source in the event that powerdistribution module 504 does not receive power from input power 560. Atother times, power distribution module 504 may serve to charge battery506 when needed.

Other components of platform subsystem 502 can include connector panel508, control panel 516, and ring 514. Connector panel 508 may serve toconnect different devices and components to robot 500 and/or associatedcomponents and modules. Connector panel 508 may contain one or moreports that receive lines or connections from different components. Forexample, connector panel 508 may have a ground terminal port that mayground robot 500 to other equipment, a port to connect foot pedal 580 torobot 500, and/or a port to connect to tracking subsystem 530. Thetracking subsystem 530 can include a position sensor 532, cameraconverter 534, and the marker tracking camera 570 which may be supportedby a camera stand. Connector panel 516 can include other ports to allowUSB, Ethernet, HDMI communications to other components, such as computer520.

Control panel 516 may provide various buttons or indicators that controloperation of robot 500 and/or provide information regarding robot 500.For example, control panel 516 may include buttons to power on or offrobot 500, lift or lower stabilizers 555-558 that may be designed toengage casters to lock robot 500 from physically moving and/or to raiseand lower the robot base and/or a vertical support for the robot arm.Other buttons may control robot 500 to stop movement of a robot arm inthe event of an emergency, which may remove all motor power and applymechanical and/or electromechanical brakes to stop all motion fromoccurring. Control panel 516 may also have indicators notifying the userof certain system conditions such as a line power indicator or status ofcharge for battery 506.

Ring 514 may be a visual indicator to notify the user of robot 500 ofdifferent modes that robot 500 is operating under and certain warningsto the user.

Computer 522 of the computer subsystem 520 includes at least oneprocessor circuit (also referred to as a processor for brevity) and atleast one memory circuit (also referred to as a memory for brevity)containing computer readable program code. The processor may include oneor more data processing circuits, such as a general purpose and/orspecial purpose processor, e.g., microprocessor and/or digital signalprocessor. The processor is configured to execute the computer readableprogram code in the memory circuit to perform operations, which mayinclude some or all of the operations described herein as beingperformed by a surgical robot and may further perform some or all of theoperations described herein as being performed by a surgical implantplanning computer.

The program code includes an operating system and software to operaterobot 500. Computer 522 may receive and process information from othercomponents (for example, tracking subsystem 530, platform subsystem 502,and/or motion control subsystem 540) in order to display information tothe user. Further, computer subsystem 520 may include speaker 526 toprovide audio notifications from the computer 522 to the user.

Tracking subsystem 530 can include position sensor 532 and cameraconverter 534. The position sensor 532 may include the marker trackingcamera 570. Tracking subsystem 530 may track the location of markersthat are located on the different components of robot 500 and/orinstruments used by a user during a surgical procedure. This trackingmay be conducted in a manner consistent with the present disclosurewhich can include the use of infrared technology that illuminates andenables tracking by the camera 570 of the location of active or passiveelements, such as LEDs or reflective markers, respectively. Thelocation, orientation, and position of structures having these types ofmarkers may be provided to computer 522 which may be shown to a user ondisplay 524 and/or tablet 590. For example, a surgical instrument orother tool having these types of markers and tracked in this manner(which may be referred to as a navigational space) may be shown to auser in relation to a three dimensional image of a patient's anatomicalstructure, such as a CT image scan, fluoroscopic image, and/or othermedical image.

The robot 500 can include a robot base that is coupled to a robot armwhich is movable by the motors, e.g., one or more of motors 550-554,relative to the robot base. The robot arm can include an upper armconnected to a vertical support and a lower arm that is rotatablycoupled to an end of the upper arm and extends to couple to theend-effector 544. Motion control subsystem 540 may be configured tophysically move a vertical column of the robot 500, e.g., raise andlower the robot arm and/or the robot base in a vertical direction, movean upper arm of the robot 500, move a lower arm of the robot 500, and/orrotate the end-effector 544. The physical movement may be conductedthrough the use of one or more motors 550-554. For example, motor 550may be configured to vertically lift or lower the robot base and/or therobot arm in a vertical direction. Motor 551 may be configured tolaterally move an upper arm around a point of engagement. Motor 552 maybe configured to laterally move a lower arm around a point of engagementwith the upper arm. Motors 553 and 554 may be configured to move theend-effector 544 in a manner that controls the roll and/or tilt, therebyproviding multiple angles that end-effector 544 may be moved. Thesemovements may be performed by controller 546 responsive to commands fromthe computer 522 and which may control these movements through loadcells disposed on the end-effector 544 and activated by a user engagingthese load cells to move the end-effector 544 in a desired manner.

The robot 500 may augment manual input by a user, e.g., when a userapplies force to one or more load cells on the end-effector 544, and/orprovide automatic movement of the robot arm. The robot 500 may alsoaugment manual movement by a user and/or provide automatic movement of avertical column of the robot base. For automatic movement, the computer522 may respond to receiving input from a user, such as by indicating ondisplay 524 (which may be a touchscreen input device) the location of asurgical instrument or component on a three dimensional medical image ofthe patient's anatomy on display 524. The computer 522 can control oneor more of the motors 550-554 to perform automatic movement of the robotarm along a trajectory that has been computed to move the end effector544 based on location of the user's input relative to the medical image.The user may initiate automatic movement by stepping on foot pedal 580and/or by manipulation of another user interface.

Instruments End Effector

The end-effector is the interface between the robotic arm and the systemspecific surgical instruments. It allows for a rigid connection throughthe sterile drape to provide precise positioning of instruments placedwithin its guide tube. The end-effector is provided as a separatecomponent and is sterilized by the user prior to use. FIG. 11illustrates the isometric and top view of the end-effector 1122including a guide tube 1122.

The end-effector is powered wirelessly from the robotic arm. This poweris used to drive the active markers that are used by the camera toidentify the location and orientation of the end-effector. The blueindicator LED illuminates when the end-effector is powered.

Two end-effectors are available to interface with various surgicalinstruments. They differ only in the diameter of the guide tube; theactive markers have the same geometries. The end-effectors are etchedwith the guide tube diameter and are color-coded to help ensure that thecorresponding size instruments are used.

The 15 mm end-effector is used with all navigated instruments exceptREVOLVE® instruments, and the 17 mm end-effector is used with REVOLVE®instruments. Non-navigated Globus instruments may be used with eitherend-effector; they are not sized to the guide tube, but must fit withinthe inner diameter

Instrument Sensing Ring

Located within the guide tube of the end-effector is an instrumentsensing ring. A detector circuit is embedded within the sensing ringthat detects when a metal instrument is inserted through the guide tubeand disables the active markers and prevents movement of the roboticarm. The visible LED on the end-effector does not illuminate when ametallic instrument is inserted, indicating that an instrument isdetected and the active IR emitters are disabled. Disabling the IRemitters prevents the robotic arm from moving. Non-metallic instrumentsare not identified by the sensing ring and may not be used in the guidetube. Detent Mechanism

Size 15 mm end-effectors have a detent mechanism on the inside of thetube which interfaces with grooves on the array sleeves to resist arrayrotation. This aids in holding the tracking array oriented toward thecamera while the operator rotates the instrument. FIG. 12 illustratesthe detent mechanism 120 on the instrument sensing ring.

Scalpel

A specialized scalpel can be used to create a skin mark at the plannedtrajectory. Attach a standard scalpel blade to the handle.

Position the guide tube on the end-effector to the planned trajectory.Adjust the end-effector up or down along the trajectory to allow thescalpel to be viewed. Ensure that scalpel tip can be viewed beforemaking the skin mark.

Note: The scalpel has a metal core within the radiolucent PEEK materialand is detected while in the guide tube. FIG. 13 illustrates a scalpelused through the guide tube.

Cannulas

Cannulas, or dilators, can be used for performing minimally invasive orother techniques that require sequential tissue dilation. The cannulasshould only be used under trajectory guidance. Note: The terms “cannula”and “dilator” are used interchangeably.

Prior to performing sequential tissue dilation, a scalpel may be usedthrough the guide tube to create a skin mark at the desired trajectory.Move the guide tube away from the trajectory using the bracelet, andcreate an incision with a scalpel. Refer to the Scalpel section of thismanual for instructions.

Once the guide tube is at the desired trajectory, position the outercannula under the guide tube and above the incision, along the sametrajectory. Insert the two inner cannulas into the guide tube andthrough the outer cannula, and rest on the skin. To sequentially dilatethe tissue, slowly insert the first (smallest) cannula into the incisionusing a cannula pusher. Then advance the second cannula in the samemanner. Complete tissue dilation by slowly advancing the outer cannulaover the inner cannula. Remove the inner cannula. Lower the guide tubeuntil it sits just within the outer cannula. Perform surgery through theguide tube and outer cannula. FIG. 14 illustrates the trajectory of theouter cannula. Referring to FIG. 14, a first inner cannula 1400 is slidinto a second inner cannula 1402 along trajectory 1404 into the outercannula 1406 which is placed within the incision 1408. FIG. 15illustrates one technique for dilating tissue with the devices. FIG. 15aillustrates how the outer cannula is positioned above the incision. FIG.15b illustrates how the cannulas is placed into the guide tube such thatit rests on skin. FIG. 15c illustrates how the first inner cannula isinserted into the incision. FIG. 15d illustrates how the second innercannula is then inserted into the incision. FIG. 15e illustrates how theouter cannula is then inserted into the incision. FIG. 15f illustratesboth inner cannulas then being removed. FIG. 15g illustrates loweringthe guide tube until it sits within the outer cannula.

Navigated Instruments

The navigated surgical instruments for use with robotic computer systeminclude drills, awls, probes, taps, and drivers, which may be used toinsert Globus screws. These instruments can be used with arrays ifnavigation is desired, or without arrays if navigation is not used. Eachinstrument and corresponding array must be assembled prior to use.Instruments are identified by a unique array pattern that is recognizedby the camera.

Navigated instruments are available for each Globus implant system.Refer to the specific system instrument brochures for more information.FIG. 16 illustrate some embodiments of the navigated instruments. Theinstruments include an awl 1600, a probe 1602, a drill 1604, a tap 1606,and a driver 1608.

Arrays

Arrays have 4 posts for attaching reflective markers and are availablefor use with the surgical instruments. The navigated surgicalinstruments are assembled to a corresponding instrument array, designedwith a unique marker pattern which identifies the instrument type. Thearray is etched with the specific instrument type, e.g. “AWL”, “PROBE”,“DRILL”, “TAP”, “DRIVER”. Each instrument array has a verificationdivot, used for instrument verification.

The verification probe has a built-in array with posts for thereflective markers and is used to verify each instrument before use.

Arrays used with instruments for the standard 15 mm end-effector areidentified by a black sleeve. Arrays used with instruments for the 17 mmend-effector are identified by a tan sleeve. FIG. 17 illustrates thearray 1700 with a release button 1702, a handgrip 1704, a marker post1706, an array sleeve 1708, and array support 1710. FIG. 17 alsoillustrates a verification divot 1712 between the array 1700 and thehandgrip 1704. FIG. 18 illustrates the verification probe.

Patient Attachment Instruments

Patient attachment instruments are secured to the patient's rigidanatomy, depending on the specific surgical procedure or preference, andare available in various configurations. These instruments may besecured to a variety of anatomical sites. The rod attachment instrumentis designed to attach to an existing spinal rod.

Patient attachment instruments must be safely and rigidly secured to thepatient to achieve navigation and guidance accuracy. Verify secureattachment by applying a light force to the distal end of the attachmentinstrument in all directions. If secure attachment is not maintainedduring the procedure, the surveillance marker will demonstrate excessivemovement; if this occurs, reposition the patient attachment instrumentand re-register the patient to the patient images.

Refer to the specific procedure in the Application section forrecommended anatomical locations. FIG. 19 illustrates the patientattachment instruments, which include a bone clamp 1900 withsurveillance marker, a quattro spike 1902, a low profile quattro spike1904, and a rod attachment 1906.

Bone Clamps

Bone clamps are clamped onto anatomical structures such as the spinousprocess, iliac crest, long bone, or any rigid bony structure that can besafely clamped.

The bone clamp is placed onto rigid bony anatomy. The clamp driver isused to tighten the bone clamp. To remove, loosen the bone clamp withthe clamp driver, attach the removal tool and lift up the bone clamp.FIG. 20 illustrates tightening bone clamp using clamp driver.

Quattro Spikes

Quattro spikes are inserted into rigid bone of the iliac crest or longbone. The quattro spike is inserted into rigid bony anatomy and gentlyimpacted with a mallet.

The low profile quattro spike is inserted using a guide post andimpaction cap. Find the desired anatomy using the guide post. Place thepatient attachment instrument over the guide post. Attach the impactioncap (for low profile quattro spike). Gently impact the assembly with amallet to insert into bony anatomy. Remove the impaction cap and guidepost from the spike. FIG. 21 illustrates the guide post 2100 and thequattro spike 2102. FIG. 22 illustrates one method for inserting thequattro spike into rigid bony anatomy. FIG. 22(a) illustratespositioning the quattro spike over the guide post. FIG. 22(b)illustrates attaching the impaction cap. FIG. 22(c) illustratesinserting the assembly into a rigid anatomy. FIG. 22(d) illustratesremoving the cap and guide pose.

Rod Attachment Instrument

The rod attachment instrument is designed to attach to an existingspinal rod (4.5 mm to 6.35 mm diameter). Position the instrument on theexisting spinal rod and tighten the set screw with a driver. Ensure arigid connection. To remove, loosen the set screw and disengage from therod. FIG. 23 illustrates the rod attachment instrument 2300 including aset screw 2302, which are attached to the existing spinal rod.

Surveillance Marker

FIG. 24 illustrates a surveillance marker. The surveillance marker is asingle reflective marker used to monitor a shift in the DynamicReference Base (DRB). Surveillance markers may be used alone or inconjunction with a bone clamp.

Surveillance markers are directly inserted into the iliac crest or longbone, or may be attached to the spinous process using a bone clamp. FIG.25 illustrates the use of a surveillance marker with a bone clamp. Touse a bone clamp with the marker, attach a disposable surveillancemarker 240 onto the tip of the bone clamp. Use the clamp driver tosecure the bone clamp. Verify that the bone clamp is rigidly secured.

Registration Instruments

The Dynamic Reference Base (DRB) and patient attachment instruments areused in the patient registration process.

The DRB is an array with 4 posts for reflective markers and allows thecamera to track the location of the patient. The DRB may be attached toany of the patient attachment instruments, using the knob andcompression clamp. FIG. 26 illustrates the dynamic reference base, whichincludes marker posts 2600 connected to a compression clamp 2602operated by a DRB knob 2604.

Registration Fixtures Intra-Op Ct Registration Fixture

The intra-op CT registration fixture, consisting of a registrationfixture and pivoting arm, allows for any intra-operative CT image to beused with the robotic computer system software application. The pivotingarm and registration fixture are assembled prior to use by matching thestarburst gears and snapping the two components together.

The intra-op registration fixture is placed onto a patient attachmentinstrument by clamping the compression clamp onto the shaft of theattachment instrument, allowing the fixture to hover over the surgicalsite. The fiducials are detected automatically in the intra-operativescan and are used to register the patient's anatomy during the scan tothe DRB, which is tracked by the camera throughout the procedure. Thereflective markers are detected by the camera. Once the registration istransferred to the DRB, the intra-op registration fixture is removed toprovide access to the surgical site. FIG. 27 illustrates the intra-opregistration fixture 2712 and pivoting arm 2708. FIG. 27 furtherillustrates the compression clamp 2602, the DRB knob 2604, a starburstconnection 2406, a gear tooth joint 2710, and a set of seven fiducials2714.

Fluoroscopy Registration Fixture

FIG. 28 illustrates the Fluoroscopy Registration Fixture. TheFluoroscopy Registration Fixture allows for any intra-operativefluoroscopic image to be used with the robotic computer system softwareapplication. The fluoroscopy fixture is attached to the imageintensifier of the fluoroscope using the integrated clamps. Thefluoroscope and Fluoroscopy Registration Fixture are draped and thereflective markers are placed on the fixture, outside of the drape. Thefixture should be positioned such that the reflective markers are seenby the camera in all intended fluoroscope positions (AP, lateral, etc).

Robotic Arm Motion

The robotic computer system robotic arm positions the end-effector toguide instruments for screw insertion at the desired trajectory. Thesurgeon manually performs surgery while the instruments are aligned inthe desired trajectory for accurate screw placement. Note: The terms“screw plan”, “screw trajectory” and “trajectory” are usedinterchangeably in this manual.

Motion of the robotic arm is only allowed with continuous pressing ofthe bracelet or foot pedal. The arm is manually moved by the user inWrist mode, or is automatically moved to the selected trajectory inTrajectory mode.

In Wrist mode, the arm may be moved manually to any position withinreach of the arm.

In Trajectory mode, the arm is automatically moved from the currentposition to the next screw plan when ready, or may be moved manuallyalong a selected trajectory.

When moving from one screw plan to the next, the arm moves outwardsalong the current trajectory to a safe distance (200 mm) from thesurgical site before moving to the new trajectory and downwards alongthe current trajectory to the anatomy.

Robotic arm motion modes

User Automatic Manual Mode Software Action Motion Motion Wrist No PlanPress Foot n/a User may move Mode Selected Pedal or arm in Squeeze thedesired Bracelet direction Trajectory Plan Press Foot Arm moves Afterreaching the mode Selected Pedal or automatically trajectory, Squeeze tonew screw user may Bracelet trajectory move arm along trajectory only

Automatic motion of the arm occurs when moving the guide tube from thecurrent position (either initially or at a current trajectory) to a newscrew plan. Once the end-effector and attached guide tube have moved toa new screw plan, the guide tube is locked onto the trajectory and canbe moved up and down along the trajectory. FIG. 29 illustrates the endeffector motion when moving from one trajectory to the next, wherein 1,2, and 3 are automatic movements; 4 is manual and optional. Theillustrated movements include movement up along path 2902 from astarting position 2900 to clear the screw and patient, movement along anew trajectory path 2904, movement downward to a safe starting positionalong path 2906, and an optional movement along a trajectory path 2908that may involve manual movement.

Automatic motion of the robotic arm may be stopped by the user, stoppedby the system, or prevented.

To stop motion at any time, press the Emergency Stop button located onthe base station.

Motion is stopped if the end-effector detects a force greater than 50N(11 lbs).

Motion is also stopped in Trajectory mode when the DRB or theend-effector is not in view of the camera.

Motion is prevented when the sensing ring in the guide tube detects ametallic instrument.

When a trajectory is selected, motion of the arm with guide tube is onlyallowed along the trajectory.

Stopping or Preventing Robotic Arm Motion

Method Emergency Stop button pressed End Effector detects force on armgreater than 50N (11 lbs) Dynamic reference base not in view of camera(Trajectory mode only) End Effector not in view of camera (Trajectorymode only) Sensing ring detects a metallic instrument in the guide tube

If the robot arm is not able to reach to a safe starting location due toits current position, an error message is shown. The message states “Thearm cannot move back any further along the current end-effectortrajectory. Acknowledging this message enables the arm to move to theselected plan trajectory from its current position”. The user may chooseto move forward with the planned trajectory because the shorter startingposition is acceptable. If the shorter starting position is notacceptable, a new trajectory must be used or the base must berepositioned.

To select a new trajectory, the user clears the selected trajectory andpositions the robotic arm using the bracelet to a clear position. Thebracelet provides flexibility for the user to move the arm around anobstacle.

To reposition the base, the stabilizers on the casters are disengaged,the station is moved to the desired location and the stabilizers arereengaged. Registration is unaffected because the patient reference(attachment instruments and DRB) has not moved with respect to thepatient.

System Software

The system software is responsible for all motion control functions,navigation functions, data storage, network connectivity, usermanagement, case management, and safety functions.

The top navigation bar takes the user through individual screens foreach step of the procedure.

The respective tab for each step is highlighted when selected and thecorresponding screen displayed. The activities performed under each tabare shown in the table below.

System Software Tabs

Tab Meaning Configure Surgeon, imaging workflow, and anatomy selectionPreplan Implant system selection and desired anatomical locationidentification Verify Navigated instrument verification Image Loading ofpatient images used for planning and navigation Plan Estimation ofdesired implant location with respect to patient images Navigate Screwplan with real-time display of navigated instrument and implant (actualplan) with respect to patient images

System Setup Power Up

FIG. 30 illustrates the power button 3000, line power indicator 3002 andbattery indicator 3004. Press the Power Button 3000 on the control panelto turn the system on. The Power Button 3000 is illuminated when thesystem is on.

Undocking and Positioning Camera Stand

To release the camera stand from the Robotic Base Station, unwrap thecord holding the monitor arm and the camera arm together, and pull up onthe release handle located on the camera stand. Once the legs of thecamera stand have cleared the base station, they will automaticallyrelease and move outward. FIG. 31 illustrates the camera standundocking. FIG. 31(a) illustrates pulling up on the release handlelocated on the camera stand. FIG. 31(b) illustrates clearing the legs ofthe camera stand legs automatically releasing and moving outward.

Unwrap the camera cord from the cord holder and plug into the connectorpanel on the base station.

Move the camera to the operating room (O.R.) table and engage the wheelbrakes by stepping on the lever located on the wheel.

Align the camera to view the surgical field.

FIG. 32 illustrates the connection of the camera to the connector panelon the base station. FIG. 33 illustrates the camera positioning.

Press and hold the laser button located on the positioning handle of thecamera to activate the camera's alignment laser and adjust the positionso the laser points to the center of the surgical field. FIG. 34illustrates pressing the laser button 3400 to activate a laser whichfacilitates user alignment of the camera.

Draping

A special surgical drape is designed for the robotic computer systemRobotic Base Station. Drape the robotic arm, monitor and front of thebase station, by following the instructions detailed in the packageinsert provided with the sterile drape. FIG. 35 illustrates the systemwith a sterile drape.

Positioning the Robotic Base Station

Unwrap the foot pedal from the foot pedal basket and position it on thelevel ground at a comfortable distance from the operator's feet. Thefoot pedal is IPX68 rated and is acceptable for use in areas whereliquids are likely to be found. Plug the foot pedal cord into theconnector panel. The foot pedal allows the arm to move to the activetrajectory, similar to the action of the bracelet on the lower arm.

Position the Robotic Base Station next to the patient at a comfortabledistance from the surgeon. Move the robotic arm, using the bracelet,around the planned trajectories to ensure the arm can reach alllocations before engaging the stabilizers. FIG. 36 illustrates the footpedal cable connection.

Press the Stabilizers Engage button on the control panel to lower thestabilizers on the casters. The button is illuminated when thestabilizers are engaged. FIG. 37 illustrates the buttons which areilluminated when the stabilizers engage (e.g. responsive to pressing thestabilizers engage button 3700) and stabilizers disengage (e.g.responsive to pressing the stabilizers disengage 3702).

Attaching End Effector to Robotic Arm

The end effector connects to the robotic arm through the interface plateover the custom drape. A magnetic assist helps to position andself-align the end effector.

The end effector is equipped with a drape-friendly clamp that allows itto be removed and reattached up to 3 times during a procedure withoutdamaging the drape. FIG. 38 illustrates the robotic arm interface platefor connection to the end effector.

FIG. 39 illustrates opening the brackets on the end effector and placethe end effector on the interface plate by aligning the V grooves andalignment spheres.

FIG. 40 illustrates squeezing the brackets on both sides of the endeffector and press the handle down to lock into place.

FIG. 41 illustrates the correct and incorrect positioning of the handledown to lock into place.

Removing the End Effector

To remove the end-effector from the robotic arm, pull up on the handleto release the spring and side brackets. FIG. 42 illustrates the removalof the end effector.

Surgical Instrument Assembly

To assemble the surgical instruments for navigation, press the releasebutton on the array sleeve and insert the instrument shaft into thesleeve of the respective instrument array. Slide the shaft through thesleeve until it clicks into place. Gently pull up on the instrumentshaft to confirm it is locked. FIG. 43 illustrates inserting theinstrument shaft into the array sleeve, and further illustrates arelease button 4300 which releases the array.

Attach a quick connect handle on the proximal end of the shaft whenneeded. To remove the instrument from the array, push the release buttonlocated on the middle of the array. FIG. 44 illustrates the surgicalinstrument assembly. FIG. 45 illustrates attaching the quick connecthandle on the proximal end of the shaft of the surgical instrumentassembly.

Attach the disposable reflective markers to each of the marker posts ofeach instrument assembly. Ensure that the markers are fully seated onthe posts. FIG. 46 illustrates attaching a reflective marker to one of aplurality of marker posts of the instrument assembly. FIG. 46(a)illustrates lowering the reflective marker onto a marker post. FIG.46(b) illustrates the marker fully seated on the post.

Login

To login, type the four-digit pin on the touch screen of the monitor.The four digit pin is provided during system installation and can bechanged by contacting Tech Support. FIG. 47 illustrates the login screendisplayed on the monitor.

A case encompasses all of the data associated with performing aprocedure, including surgeon preferences, medical images, and plans.

After logging in, the SELECT CASE page is displayed on the monitor.

To select an existing case, select the corresponding row from the caselist. To start a new case, click the new case icon. Click the rightarrows to advance to the next tab. FIG. 48 illustrates the casemanagement screen displayed on the monitor.

Applications

Spine surgical procedures are supported by the robotic computer system.FIG. 49 illustrates the CONFIGURE tab used to display procedure types.

Spine Procedures

Spinal surgical applications supported by the robotic computer systemsystem are listed below.

Supported Spine Procedures

Procedures Patient Position Posterior Cervical Prone Posterior ThoracicProne Anterolateral Thoracic Lateral Posterior Lumbar Prone LateralLumbar Lateral

Globus spinal implant systems that are compatible with the roboticcomputer system are listed below.

Compatible Spinal Implant Systems

CREO ® Stabilization System REVERE ® Stabilization System REVOLVE ®Stabilization System ELLIPSE ® Occipito-Cervico-Thoracic Spinal SystemQUARTEX ® Occipito-Cervico-Thoracic Spinal System SI-LOK ® SacroiliacJoint Fusion System

Procedure Setup Configure Tab

After selecting a case, the CONFIGURE tab is displayed on the monitor.

Using the CONFIGURE tab, select the surgeon, the imaging modality andthe procedure type. Click the right arrows to advance to the next tab.

Preplan Tab

Using the PREPLAN tab, select the implant system, desired vertebrallevel and orientation, and click the desired implant location on theanatomical model. Click the right arrows to advance to the next tab.FIG. 50 illustrates the PREPLAN tab displayed on the monitor to selectthe implant system, desired vertebral level and orientation.

Verify Tab

FIG. 51 illustrates the VERIFY tab displaying navigation detailsincluding visibility, location and verification status of theinstruments selected on the PREPLAN tab. Verification is used to ensureall instruments are accurate and have not been damaged during handlingand sterilization. The operator must assemble all instruments prior toverification (see Surgical Instrument Assembly).

The VERIFY tab shows CAMERA VIEW and INSTRUMENT STATUS.

CAMERA VIEW is a real-time view from the perspective of the camera withcolor circles indicating instrument location. A solid colored circleindicates that the instrument is visible by the camera, while a hollowcircle indicates that it is not visible. The colored circle grows largeras the instrument is moved closer to the physical camera and smaller asit moves away from the camera. The ideal distance from the camera isapproximately 2 meters or 6 feet.

INSTRUMENT STATUS lists each instrument and its verification status,with corresponding color circles to identify each instrument. Theverification status is symbolized by a checkmark if verification issuccessful and an X-mark if the verification failed. When no iconappears, the instrument is not verified.

Instrument Verification

Verify each instrument as follows: place the tip of the instrument to beverified into verification divots located on the end-effector and on anyother instrument array for convenience; ensure both instruments arevisible and held steady; and use a pop-up screen appearing on the VERIFYtab to indicate the verification progress. FIG. 52 illustrates thepop-up screen appearing on the VERIFY tab to indicate the verificationprogress. FIG. 53 illustrates the verification divot 1712 which betweenthe hand grip 1704 and the array 1700.

Once verification is complete, verification status is indicated on thescreen with the tip error displayed in mm. If verification has failed(red crossed circle), verification must be repeated until it issuccessful (green circle).

When all instruments are successfully verified, advance to the next tab.FIG. 54 illustrates the green circle indicating a successfulverification. FIG. 55 illustrates the red crossed circle indicating afailed verification.

Patient Attachment Instruments

Patient attachment instruments are secured to rigid bony anatomyneighboring the surgical site. Select the desired instrument. Patientattachment instruments should be placed no more than 185 mm from thecenter of the surgical site to maintain accuracy.

Bone clamps are clamped onto anatomical structures such as the spinousprocess, iliac crest, long bone, or any rigid bony structure that can besafely clamped.

Quattro spikes are inserted into the iliac crest or a long bone.

Rod attachments are secured to an existing spinal rod, 4.5 mm to 6.35 mmin diameter.

Refer to the table below for recommended anatomic locations for thevarious patient attachment instruments.

Patient Attachment Instruments—Recommended Anatomic Locations

Patient Recommended Patient Spine Patient Attachment AttachmentInstrument Procedures Position Instrument Location Posterior Prone BoneClamp Spinous Process Cervical C2-T3 Rod Attachment Existing RodPosterior Prone Bone Clamp Spinous Process Thoracic T1-L1 Rod AttachmentExisting Rod Anterolateral Lateral Bone Clamp Spinous Process ThoracicT1-L1 Posterior Prone Quattro Spike Iliac Crest Lumbar Low Profile IliacCrest Quattro Spike Bone Clamp Spinous Process T12-L5 Rod AttachmentExisting Rod Lateral Lumbar Lateral Quattro Spike Iliac Crest LowProfile Iliac Crest Quattro Spike Bone Clamp Spinous Process T12-L5 RodAttachment Existing Rod

Dynamic Reference Base Insertion

Position the compression clamp on the Dynamic Reference Base (DRB) overthe patient attachment instrument and tighten the knob. If needed, theclamp driver can be used to further tighten the knob.

Position the reflective markers on the DRB in the direction of thecamera. Care should be taken with initial placement of the patientreference instrument as to not interfere with the surgical procedure.

Following navigation, the patient attachment instrument is removed. FIG.56 illustrates securing a Dynamic Reference Base to a patient attachmentinstrument. FIG. 57 illustrates using a clamp driver to the DynamicReference Base.

Surveillance Marker

The surveillance marker is inserted into rigid bony anatomy to track therelative distance to the DRB, to identify unwanted shifts in the DRBduring the procedure.

Surveillance markers are inserted into the iliac crest or long bone, ormay be attached to the spinous process using a bone clamp. Verify thatthe clamp is rigidly secured. The surveillance marker should be placedno more than 185 mm from the Dynamic Reference Base. Refer to the tablebelow for recommended anatomic locations.

Surveillance Marker—Recommended Anatomic Locations

Patient Recommended Patient Spine Patient Attachment AttachmentInstrument Procedures Position Instrument Location Posterior Prone BoneClamp Spinous Process Cervical C2-T3 Posterior Prone Single Iliac CrestThoracic Bone Clamp Spinous Process T1-L1 Anterolateral Lateral BoneClamp Spinous Process Thoracic T1-L1 Posterior Lumbar Prone Single IliacCrest Bone Clamp Spinous Process T12-L5 Lateral Lumbar Lateral SingleIliac Crest Bone Clamp Spinous Process T12-L5

Attach a disposable reflective marker to the marker post of thesurveillance marker. Attach the impaction cap, designed to fit over thereflective marker sphere, onto the surveillance marker. Insert thesurveillance marker into rigid bony anatomy near the surgical site, andgently impact with a mallet. Remove the impaction cap. Remove thereflective marker prior to using the removal tool. FIG. 58 illustratesthe placement of the Dynamic Reference Base (DRB) 5800 and thesurveillance marker 5804. The DRB 5800 includes reflective markers 5802.

To use a bone clamp with the marker, attach a disposable marker onto thetip of the bone clamp. Use the clamp driver to secure the bone clamp.Verify that the clamp is rigidly secured. Removal

The quattro spikes and surveillance marker are removed from bony anatomymanually or using the removal tool. The bone clamp is removed byloosening the clamp with the clamp driver, attaching the removal tooland lifting up the bone clamp. FIG. 59 illustrates a quattro spike. FIG.60 illustrates a quattro spike removal tool. FIG. 61 illustratesremoving a quattro spike with a removal tool.

Intra-Operative CT Imaging Workflow Image Tab Intra-Op Ct RegistrationFixture Setup

FIG. 62 illustrates attaching a registration fixture 6200 to a pivotingarm 6202. Place the pivoting arm starburst 6206 over the starburst 6206on the registration fixture 6200 and rotate 90° to secure. Referring tothe enlarged view 6208 of the pivoting arm 6202 positioned over thestarburst 6206, push the lock post 6204 from the bottom and rotate thearm 90° until the pin in the lock post 6204 is seated to secure thefixture. Enlarged view 6210 shows the pivoting arm 6202 attached androtated to become secured to the registration fixture 6200.

FIG. 63 illustrates a registration fixture connecting to a patientattachment instrument. Position the fixture on the patient attachmentinstrument post and tighten the compression clamp knob. If needed, theclamp driver can be used to further tighten the knob.

To release the pivoting arm, push the lock post on the fixture, rotatethe pivoting arm 90° and pull up.

The Intra-op CT Registration Fixture has six degrees of freedom and canbe moved by adjusting one of the three joints so that it is stable andhovering over the surgical site. Only the metal fiducials embedded inthe fixture need to be in the 3D scan (not the reflective markers). Itis important that the Intra-op CT Registration Fixture does not movebetween the image acquisition and performing an anatomical landmarkcheck.

Loading the Image

The IMAGE tab shows the steps needed to load a CT scan image. The imagecan be loaded from a USB drive or hard drive. If the image istransferred via the Ethernet, it automatically appears on the hard drivewhen the transfer is complete.

To view images on a USB drive, insert the USB drive into the USB port onthe connector panel. To load an image, select the hard drive or USBdrive icon and select the desired patient image. Click the right arrowsto load the patient images and advance to the next tab.

Manual Registration

Automatic registration is performed when loading images. FIG. 64illustrates a registered fiducial. If this step fails, the manualregistration screen will be shown to allow manual registration asdescribed below.

The image on the left panel of the registration screen is a full scanwith a depiction of the intra-op CT.

The registration fixture and the seven fiducials should be visible belowthe image. Fiducials that are not registered need to be adjusted by theoperator. On the screen, select a fiducial that is not registered; thatimage will appear on the right. Move the blue circle on the screen untilit surrounds the white fiducial marker. The three small boxes at thebottom of the right panel show the x, y and z direction of the fiducialand all must be adjusted until the blue circle is centered. Ensure thatall seven fiducials are properly identified by viewing the 3D model ofthe intra-op registration fixture. A fiducial may be deleted byselecting the delete icon on the right panel. Click the right arrows toconfirm that the fiducials have been properly identified beforeproceeding to the next step.

Landmark Check

After registration has been completed, a landmark check should beperformed to ensure that the registration was calculated successfully.Using the verification probe, touch an anatomical landmark or a fiducialon the registration fixture and verify that the corresponding locationis shown on the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the Intra-op CT Registration Fixture. Ensure thepatient attachment instrument does not move.

Intra-Operative CT Imaging Workflow Plan Tab

FIG. 65 illustrates the PLAN tab allowing the user to plan all screwtrajectories on the patient image. Screws are preloaded on the righthand side of the screen, based on selections made in the PREPLAN tab.

To add a screw onto the planning page, drag and drop the appropriatescrew label on the image at the desired slice.

The active screw plan is shown in green. Details of the active screwplan are shown on the lower right of the screen, including screw family,diameter, and length. Click on the right arrows to advance to the nexttab once plans are complete for all screws.

Adjusting Screw Trajectory

Screw Body Press and move along screen to translate the screw along thecurrent plane of the anatomy Screw Head Press and move to change theangle of the trajectory, pivoting along the tip of the screw Screw TipPress and move to change the angle of the trajectory, pivoting along thehead of the screw Scroll Bar The scroll bar is the dial control locatedabove the head of the screw. Press the scroll bar and move to rotate theanatomy 360° about the screw.

Adjusting Screw Size

Screw Press and move longitudinally to automatically adjust the Tiplength of the screw to available screw sizes Screw Press the screwdiameter button located on the right hand Diameter side of the screen toselect other options available with the selected implant set Screw Pressthe screw length button located on the right hand Length side of thescreen to select other options available with the selected implant set

Intra-Operative CT Imaging Workflow Planning Operations

FIG. 80 illustrates a block diagram of a surgical system 600 thatincludes a surgical implant planning computer 610 which may be separatefrom and operationally connected to the robot 500 or at least partiallyincorporated therein. Alternatively, at least a portion of operationsdisclosed herein for the surgical implant planning computer 610 may beperformed by components of the robot 500 such as by the computersubsystem 520.

Referring to FIG. 80, the surgical implant planning computer 610includes a display 612, at least one processor circuit 614 (alsoreferred to as a processor for brevity), at least one memory circuit 616(also referred to as a memory for brevity) containing computer readableprogram code 618, and at least one network interface 620 (also referredto as a network interface for brevity). The network interface 620 can beconfigured to connect to a CT image scanner 630, a fluoroscopy imagescanner 640, an image database 650 of medical images, components of thesurgical robot 500, the marker tracking camera 570, and/or otherelectronic equipment.

When the surgical implant planning computer 610 is at least partiallyintegrated within the surgical robot 500, the display 612 may correspondto the display 524 and/or the tablet 590, the network interface 620 maycorrespond to the platform network interface 512, and the processor 614may correspond to the computer 522.

The processor 614 may include one or more data processing circuits, suchas a general purpose and/or special purpose processor, e.g.,microprocessor and/or digital signal processor. The processor 614 isconfigured to execute the computer readable program code 618 in thememory 616 to perform operations, which may include some or all of theoperations described herein as being performed by a surgical implantplanning computer. FIGS. 81 through 87 illustrates various operationsthat can be performed by the processor 614 in accordance with someembodiments of the present disclosure.

Referring to FIGS. 80 and 81, the processor 614 displays 700 on thedisplay device a CT image of a bone that is received from the CT imagescanner 630 through the network interface 620. The processor 614receives 702 a user's selection of a surgical screw from among a set ofdefined surgical screws, such as by a user touch selectinguser-selectable indicia shown through a touch sensitive screen overlayon the display 612. The processor 614 displays 704 a graphical screwrepresenting the selected surgical screw as an overlay on the CT imageof the bone.

The processor 614 controls 706 angular orientation and location of thedisplayed graphical screw relative to the bone in the CT imageresponsive to receipt of user inputs, which may be provided by the usertouch selecting and/or touch dragging a finger on the display 614 and/orvia another user interface, such as a touchpad, joystick, dials, etc.The processor 614 stores 708 an indication of the selected surgicalscrew and an angular orientation and a location of the displayedgraphical screw in a surgical plan data structure, e.g., within memory616, responsive to receipt of a defined user input, such as a userselecting a displayed indicia for providing a keyboard input. As will bedescribed in further detail below, the processor 614 may control 710 therobot 500 based on the surgical plan data structure to move the robotarm relative to a patient.

The angular orientation and the location that is stored 708 in thesurgical plan data structure may be configured to indicate the angularorientation and the location of the displayed graphical screw relativeto an angular orientation and a location of the bone in the CT image.The operations to display 704 the graphical screw representing theselected surgical screw as an overlay on the CT image of the bone, caninclude determining a trajectory along an axis of the graphical screw,and displaying a trajectory line that extends from adjacent to a tip ofthe graphical screw and along the trajectory to facilitate a uservisually orienting and positioning the graphical screw relative to adesired insertion location on the bone.

The operations to control 706 angular orientation and location of thedisplayed graphical screw relative to the bone in the CT imageresponsive to receipt of user inputs, can include translating a locationof the displayed graphical screw responsive to determining that the userhas pressed on a touch-sensitive screen of the display device 612 over ascrew body of the graphical screw while moving location of the user'scontinued pressing along the touch-sensitive screen. The operations canfurther include angularly pivoting the displayed graphical screwresponsive to determining that the user has pressed on thetouch-sensitive screen over a screw head and/or tip of the graphicalscrew while moving location of the user's continued pressing along thetouch-sensitive screen.

Alternatively or additionally, the operations to control 706 angularorientation and location of the displayed graphical screw relative tothe bone in the CT image responsive to receipt of user inputs, caninclude selecting a length of the displayed graphical screw from among aset of defined lengths for surgical screws responsive to determiningthat the user has pressed on a touch-sensitive screen of the displaydevice over a screw tip or a screw head of the graphical screw whilemoving location of the user's continued pressing along thetouch-sensitive screen a measured distance. The selected length of thesurgical screw is then stored 708 in the surgical plan data structure.

The operations to control 706 orientation and location of the displayedgraphical screw relative to the bone in the CT image responsive toreceipt of user inputs, can include modifying a size and/or a rotationalangle of the displayed graphical screw on the CT image responsive totracking motion of a user's hand relative to an input device, such as bytracking motion of the user's finger on a touch sensitive screen overlayon the display 612, on a touchpad, etc.

Intra-Operative CT Imaging Workflow Navigate Tab

FIG. 66 illustrates the NAVIGATE tab allowing the user to visualize thenavigated instrument trajectory and the planned trajectory with respectto patient anatomy.

The robotic arm precisely aligns the end-effector to the plannedtrajectory. Select the desired screw label on the right of the screen.The screw plan is active when the screw label is highlighted and therobotic arm can be moved by the bracelet or pressing the foot pedal. Therobotic arm first moves up in order to clear obstacles in the surgicalfield and then down along the trajectory. Once on the trajectory, therobotic arm can move up/down along the trajectory but does not move offof the trajectory unless the screw plan is deselected.

The real-time instrument/implant trajectory is displayed on the patientimages along with the planned screw, allowing the user to confirm thedesired trajectory. If the real-time trajectory is not acceptable, theuser can return to the PLAN tab to select another trajectory. If thereal-time trajectory is acceptable, the user inserts the screw accordingto the instrument's current trajectory to the desired depth.

GPS instruments are displayed as they are advanced through theend-effector. While navigating the instruments, periodically observe themonitor and surgical site to ensure consistency between tactile andnavigation feedback. Non-navigated metallic Globus instruments may beused through the guide tube while it is stationary for surgicalapplications unrelated to screw placement.

Monitor the surveillance marker during the procedure. If thesurveillance marker indicates significant movement of the DRB, performan anatomical landmark check. If the landmark check is satisfactory,re-register the surveillance marker. If the landmark check fails,re-register the patient.

There are multiple navigation tab icons. Referring to FIG. 66, the forcegauge 661 indicates the force exerted on the end-effector. The image ofthe instrument at the bottom of the force gauge shows the activeinstrument in the end-effector or the end-effector image if noinstrument is inserted. The surveillance marker error gauge 662indicates the distance that the patient reference has moved in relationto the surveillance marker. The full range of the scale is 2 mm. The DRBicon 663 indicates dynamic reference base visibility. If the DRB isvisible by the camera, the background is green. If the DRB is notvisible by the camera, the background is red.

Intra-Operative CT Imaging Workflow Navigation Operations

As explained above, the surgical implant planning computer 610 cancontrol 710 operations of the surgical robot 500. Referring to theoperational embodiment of FIG. 82, the processor 614 of the surgicalimplant planning computer 610 can control 710 the robot 500 by providing800 the surgical plan data structure to the robot 500 to controlmovement of the robot arm relative to the robot base.

Referring to the alternative or additional operations of FIG. 83, theprocessor 614 of the surgical implant planning computer 610 can control710 the robot 500 by controlling 900 selected ones of the motors550-554, either directly or indirectly via the computer 522 and/orcontroller 546, responsive to content of the surgical plan datastructure to regulate movement of the robot arm while positioning anend-effector 544, which is connected to the robot arm, relative to apatient. The processor 614 can also control 902 angular orientation andlocation of the displayed graphical screw on the display 612 responsiveto the movement of the robot arm while the end-effector 544 ispositioned relative to the patient.

In a further embodiment, the processor 614 can directly or indirectlycontrol 900 one or more of the motors 550-554 to move the end-effector544 in a direction along a trajectory that is defined by the content ofthe surgical plan data structure, and can control 902 location of thedisplayed graphical screw responsive to the movement of the end-effector544 along the trajectory.

In a further embodiment, while moving the end-effector 544 along thetrajectory, the processor 614 can directly or indirectly control one ormore of the motors 550-554 to resist movement of the end-effector 544 ina direction that is perpendicular to the trajectory until anotheroperation is perform that cancels an end-effector trajectory constraintmode. In a further embodiment, prior to initiating the end-effectortrajectory constraint mode, the processor 614 can directly or indirectlycontrol one or more of the motors 550-554 to move the end-effector 544in a direction upward away from the patient and then toward a locationalong the trajectory toward the patient, and prevent initiation of theend-effector trajectory constraint mode before reaching the locationalong the trajectory. The processor can control angular orientation andlocation of the displayed graphical screw responsive to the movement ofthe robot arm away from the patient and then toward the location alongthe trajectory.

Pre-Operative CT Imaging Workflow Image Tab Loading the Image

The IMAGE tab shows the steps needed to load a CT scan image. The imagecan be loaded from a USB drive or hard drive. If the image istransferred through the Ethernet, it automatically appears on the harddrive when the transfer is complete.

To view images on a USB drive, insert the USB drive into the USB port onthe connector panel. To load an image, select the hard drive or USBdrive icon and select the desired patient image. Click the right arrowsto load the patient images and advance to the next tab.

Pre-Operative CT Imaging Workflow Plan Tab

FIG. 67 illustrates the PLAN tab allowing the user to plan all screwtrajectories on the patient image. Screws are preloaded on theright-hand side of the screen, based on selections made in the PREPLANtab.

To add a screw onto the planning page, drag and drop the appropriatescrew label on the image at the desired slice. The active screw plan isshown in green. Details of the active screw plan are shown on the lowerright of the screen, including screw family, diameter, and length. Clickon the right arrows to advance to the next tab once plans are completefor all screws.

Adjusting Screw Trajectory

Screw Body Press and move along screen to translate the screw along thecurrent plane of the anatomy Screw Head Press and move to change theangle of the trajectory, pivoting along the tip of the screw Screw TipPress and move to change the angle of the trajectory, pivoting along thehead of the screw Scroll Bar The scroll bar is the dial control locatedabove the head of the screw. Press the scroll bar and move to rotate theanatomy 360° about the screw.

Adjusting Screw Size

Screw Tip Press and move longitudinally to automatically adjust thelength of the screw to available screw sizes Screw Diameter Press thescrew diameter button located on the right hand side of the screen toselect other options avail- able with the selected implant set ScrewLength Press the screw length button located on the right hand side ofthe screen to select other options avail- able with the selected implantset

Pre-Operative CT Imaging Workflow Planning Operations

Pre-operative CT imaging workflow planning operations that can beperformed by the surgical implant planning computer 610 and, moreparticularly by the processor 614, are now described in the context ofthe embodiments shown in FIG. 84.

Referring to FIG. 84, the operations can include loading 1000 a CT imageof a bone, which is received from the image database 650 through thenetwork interface 620, into the memory 616. The operations includedisplaying 1002 the CT image on the display device 612, and receiving1004 a user's selection of a surgical screw from among a set of definedsurgical screws. The operations display 1006 a graphical screwrepresenting the selected surgical screw as an overlay on the CT imageof the bone. The operations control 1008 angular orientation andlocation of the displayed graphical screw relative to the bone in the CTimage responsive to receipt of user inputs. The operations store 1012 anindication of the selected surgical screw and an angular orientation anda location of the displayed graphical screw in a surgical plan datastructure responsive to user input. The surgical plan data structure isconfigured for use by the robot 500 to control movement of the robot armin accordance with various embodiments disclosed herein.

The operations to display 1006 the graphical screw representing theselected surgical screw as an overlay on the CT image of the bone, caninclude determining a trajectory along an axis of the graphical screw,and displaying 1010 a trajectory line that extends from adjacent to atip of the graphical screw and along the trajectory to facilitate a uservisually orienting and positioning the graphical screw relative to adesired insertion location on the bone.

The operations to control 1008 angular orientation and location of thedisplayed graphical screw relative to the bone in the CT imageresponsive to receipt of user inputs, can include translating a locationof the displayed graphical screw responsive to determining that the userhas pressed on a touch-sensitive screen of the display device 612 over ascrew body of the graphical screw while moving location of the user'scontinued pressing along the touch-sensitive screen. The operations canalternatively or additionally include angularly pivoting the displayedgraphical screw responsive to determining that the user has pressed onthe touch-sensitive screen over a screw head and/or tip of the graphicalscrew while moving location of the user's continued pressing along thetouch-sensitive screen.

The operations to control 1008 angular orientation and location of thedisplayed graphical screw relative to the bone in the CT imageresponsive to receipt of user inputs, can include selecting a length ofthe displayed graphical screw from among a set of defined lengths forsurgical screws responsive to determining that the user has pressed on atouch-sensitive screen of the display device 612 over a screw tip or ascrew head of the graphical screw while moving location of the user'scontinued pressing along the touch-sensitive screen a measured distance.

The selected length of the surgical screw is stored 1012 in the surgicalplan data structure.

The operations can include controlling 1014 angular orientation andlocation of the displayed graphical screw responsive to the movement ofthe robot arm while the end-effector 544 is being positioned relative toa patient.

Pre-Operative CT Imaging Workflow Navigate Tab

The NAVIGATE tab allows the user to visualize the navigated instrumentsand trajectory alignment with respect to patient anatomy, according tothe screw plan. Registration Setup

FIG. 68 illustrates the first screen highlighting the three steps tocomplete before the fluoroscopy images can be taken to register thepre-operative CT image. Animation visually depicts the steps.

FIG. 69 illustrates a Fluoroscopy Registration Fixture attached to imageintensifier. Attach the Fluoroscopy Registration Fixture to the imageintensifier on the C-arm by turning the clamps clockwise until tight.Drape the fluoroscope and Fluoroscopy Registration Fixture and attachnew reflective markers outside of the drape. Position the fixture suchthat the reflective markers are facing the camera. Attach the videocapture cable (yellow jack) to the C-arm viewing station. Plug the videocapture USB cable into either of the two USB ports on the roboticcomputer system connector panel.

Ensure that the Dynamic Reference Base is visible to the camera afterthe C-Arm is in place.

Register the surveillance marker by placing an instrument close to thereflective sphere on the surveillance marker but not touching. The boxturns green when it is activated. Click the right arrows to advance tothe next tab.

Pre-Operative CT Imaging Workflow Navigation Operations

Pre-operative CT imaging workflow navigation operations that can beperformed by the surgical implant planning computer 610 and, moreparticularly by the processor 614, are now described in the context ofthe embodiments shown in FIG. 85.

Referring to FIG. 85, the operations can include performing 1100 aregistration setup mode that includes determining occurrence of a firstcondition indicating that a marker tracking camera 570 can observe totrack reflective markers that are on a fluoroscopy registration fixture(e.g., connected to the fluoroscopy imager 640), and further determiningoccurrence of a second condition indicating that the marker trackingcamera 570 can observe to track dynamic reference base markers attachedto the robot arm and/or an end-effector 544 connected to the robot arm.The operations display 1102 on the display device 612 an indication ofwhen both of the first and second conditions occur, and determine thatthe registration setup mode is allowed to be marked satisfied when atleast both of the first and second conditions are determined to occur.

Registration

Acquire the intra-operative fluoroscopic images, one AP and one lateralfor each level planned. The same image may be used for multiple levels.

The following three conditions must be met prior to acquiring theimages: (1) the DRB is visible by the camera; (2) the FluoroscopyRegistration Fixture is visible by the camera; and (3) a validfluoroscopic image was taken.

FIG. 70 illustrates a lateral image within the NAVIGATE tab. Referringto FIG. 70. Each of the three images on the left of the screen turnsgreen when ready for image capture. When all three conditions are met,acquire the intra-operative fluoroscopic image and then select theCAPTURE button to transfer the image to the system. Once both images aresuccessfully captured, the spinal level on the right side of the screendisplays a check mark. Click the right arrows to advance to the nexttab.

FIG. 71 illustrates selecting the desired level. To do so, the userdrags and drops the planned screw onto the fluoroscopic images. Use thecircle control points to roughly position the screw within the vertebralbody. Ensure that the screw shank is positioned correctly, the head andtail of the screws are in the desired direction, and left/right arecorrectly oriented. Click the register button when complete to allowregistration.

FIG. 72 illustrates a successful registration with a check mark beingshown next to the active level. Click the right arrows when registrationis complete.

Pre-Operative CT Imaging Workflow Navigation Operations

With further reference to FIG. 85, the operations by the surgicalimplant planning computer 610 can further include operating 1104 whileboth of the first and second conditions are determined 1104 to continueto occur, to allow operations to be performed to obtain a firstintra-operative fluoroscopic image of the patient along a first planeand to obtain a second intra-operative fluoroscopic image of the patientalong a second plane that is orthogonal to the first plane. Theoperations determine that a registration mode is allowed to be markedsatisfied when the first and second intra-operative fluoroscopic imageshave been obtained.

With further reference to FIG. 85, the operations by the surgicalimplant planning computer 610 can further include displaying 1106 thefirst and second intra-operative fluoroscopic images on the displaydevice 612. The operations display 1108 the graphical screw as anoverlay on both of the first and second intra-operative fluoroscopicimages. The operations control 1110 angular orientation and location ofthe displayed graphical screw relative to a bone in the first and secondintra-operative fluoroscopic images responsive to receipt of userinputs.

Operations may alternatively or additionally include determining 1112when the angular orientation and location of the displayed graphicalscrew relative to the bone in the first and second intra-operativefluoroscopic images satisfies a registration rule for corresponding tothe angular orientation and the location of the displayed graphicalscrew in the surgical plan data structure, and then responsivelydisplaying on the display device 612 an indication of when theregistration rule is satisfied.

With further reference to FIG. 85, the operations by the surgicalimplant planning computer 610 can further include, based on determiningthat the registration rule is satisfied, controlling 1114 one or more ofthe motors 550-554 responsive to content of the surgical plan datastructure to regulate movement of the robot arm while positioning theend-effector 544 relative to the patient. The operations can furthercontrol 1114 angular orientation and location of the graphical screwthat is displayed, responsive to the movement of the robot arm while theend-effector 544 is being positioned relative to the patient.

Landmark Check

After registration has been completed, a landmark check, orverification, should be performed to ensure that the registration wascalculated successfully. Using the verification probe, touch ananatomical landmark and verify that the corresponding location is shownon the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the Fluoroscopy Registration Fixture if desired.

Navigation

The robotic arm precisely aligns the end-effector on the plannedtrajectory. Select the desired screw label on the right of the screen.

The screw plan is active when the screw label is highlighted and therobotic arm can be moved by the bracelet or pressing the foot pedal. Therobotic arm first moves up in order to clear obstacles in the surgicalfield and then down along the trajectory. Once on the trajectory, therobotic arm can move up/down along the trajectory but does not move offof the trajectory unless the screw is deselected.

FIG. 73 illustrates how the real-time instrument/implant trajectory isdisplayed on the patient images along with the planned screw, allowingthe user to confirm the desired trajectory. If the real-time trajectoryis not acceptable, the user can return to the PLAN tab to select anothertrajectory. If the real-time trajectory is acceptable, the user insertsthe screw according to the instrument's current trajectory to thedesired depth.

GPS instruments are displayed as they are advanced through theend-effector. While navigating the instruments, periodically observe themonitor and surgical site to ensure consistency between tactile andnavigation feedback.

Non-navigated metallic Globus instruments may be used through the guidetube while it is stationary for surgical applications unrelated to screwplacement.

Monitor the surveillance marker during the procedure. If thesurveillance marker indicates significant movement of the DRB, performan anatomical landmark check. If the landmark check is satisfactory,re-register the surveillance marker. If the landmark check fails,re-register the patient.

There are multiple navigation tab icons. Referring to FIG. 73, the forcegauge 731 indicates the force exerted on the end-effector. The image ofthe instrument at the bottom of the force gauge shows the activeinstrument in the end-effector or the end-effector image if noinstrument is inserted. The surveillance marker error gauge 732indicates the distance that the patient reference has moved in relationto the surveillance marker. The full range of the scale is 2 mm. The DRBicon 733 indicates dynamic reference base visibility. If the DRB isvisible by the camera, the background is green. If the DRB is notvisible by the camera, the background is red.

Fluoroscopic Imaging Workflow Image Tab Registration Setup

Referring to FIG. 68 the first screen highlights the three steps tocomplete before fluoroscopic images can be taken to register thepatient. Animation visually depicts the steps.

Referring to FIG. 69, attach the Fluoroscopy Registration Fixture to theimage intensifier on the C-arm by turning the clamps clockwise untiltight. Drape the fluoroscope and Fluoroscopy Registration Fixture andattach new reflective markers outside of the drape. Position the fixturesuch that the reflective markers are facing the camera. Attach the videocapture cable (yellow jack) to the C-arm viewing station. Plug the videocapture USB cable into either of the two USB ports on the roboticcomputer system connector panel.

Ensure that the Dynamic Reference Base is visible to the camera afterthe C-Arm is in place.

Register the surveillance marker by placing an instrument close to thereflective sphere on the surveillance marker but not touching. The boxturns green when it is activated. Click the right arrows to advance tothe next tab.

Image Acquisition

Acquire intra-operative fluoroscopic images, one AP and one lateral.

The following three conditions must be met prior to acquiring theimages: (1) the DRB is visible by the camera; (2) the FluoroscopyRegistration Fixture is visible by the camera; and (3) a validfluoroscopic image was taken.

FIG. 74 illustrates a lateral image within the NAVIGATE tab. Referringto FIG. 74, each of the three images on the left of the screen turngreen when ready for image capture. When all three conditions are met,acquire the intra-operative fluoroscopic image and then select theCAPTURE button to transfer the image to the system. Once both images aresuccessfully captured, the level on the right side of the screendisplays a check mark. Once the appropriate images have been loaded andselected, click on the right arrows to proceed.

Landmark Check

After registration has been completed, a landmark check, orverification, should be performed to ensure that the registration wascalculated successfully. Using the navigated verification probe, touchan anatomical landmark and verify that the corresponding location isshown on the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the fluoroscopy registration fixture if desired.

Fluoroscopic Imaging Workflow Operations

Fluoroscopic imaging workflow operations that can be performed by thesurgical implant planning computer 610 and, more particularly by theprocessor 614, are now described in the context of the embodiments shownin FIG. 86.

Referring to FIG. 86, the operations can include performing 1200operations for a registration setup mode that include determiningoccurrence of a first condition indicating that the marker trackingcamera 570 can observe to track reflective markers that are on afluoroscopy registration fixture of the fluoroscopy imager 640, anddetermining occurrence of a second condition indicating the markertracking camera 570 can observe to track dynamic reference base markersattached to the robot arm and/or the end-effector 544 connected to therobot arm. While both of the first and second conditions are determinedto continue to occur, the processor 614 allows 1204 operations to beperformed to obtain a first intra-operative fluoroscopic image of apatient along a first plane and to obtain a second intra-operativefluoroscopic image of the patient along a second plane that isorthogonal to the first plane. The operations may display 1202 on thedisplay device 612 an indication of when both of the conditions occur.If one or both conditions cease to be satisfied before the first andsecond intra-operative fluoroscopic images are obtained, the system mayinterrupt further obtaining of the uncompleted first and secondintra-operative fluoroscopic imaging and generate a notification to theuser.

The operations can further include displaying 1206 the first and secondintra-operative fluoroscopic images on the display device 612. Theoperations can receive 1208 a user's selection of a surgical screw fromamong a set of defined surgical screws, and display 1210 a graphicalscrew representing the selected surgical screw as an overlay on both ofthe first and second intra-operative fluoroscopic images. The operationscan control 1212 angular orientation and location of the displayedgraphical screw relative to a bone shown in the first and secondintra-operative fluoroscopic images responsive to receipt of userinputs, and store 1214 an indication of an angular orientation and alocation of the displayed graphical screw in a surgical plan datastructure responsive to receipt of a defined user input.

Fluoroscopic Imaging Workflow Plan Tab

FIG. 75 illustrates the PLAN tab allowing the user to plan all screwtrajectories on the patient image. Referring to 75, screws are preloadedon the right side of the screen, based on selections made in the PREPLANtab.

To add a screw onto the planning page, drag and drop the appropriatescrew label on the image at the desired slice.

The active screw plan is shown in green. Details of the active screwplan are shown on the lower right of the screen, including screw family,diameter, and length. Click on the right arrows to advance to the nexttab once plans are complete for all screws.

Adjusting Screw Trajectory

Screw Head Press and move along screen to adjust the screw along thecurrent plane of the anatomy Screw Tip Press and move to change theangle of the trajectory, pivoting along the head of the screw ScrewTrajectory Press and move the screw along the 3D trajectory. This isuseful to simulate actual advancement of the screw in 3D space. Both APand Lateral images will be updated to reflect the new screw position.

Adjusting Screw Size

Screw Diameter Press the screw diameter button located on the right handside of the screen to select other options available with the selectedimplant set Screw Length Press the screw length button located on theright hand side of the screen to select other options available with theselected implant set

Fluoroscopic Imaging Workflow Planning Operations

Fluoroscopic imaging workflow operations for planning that can beperformed by the surgical implant planning computer 610 and, moreparticularly by the processor 614, are now described in the context ofthe embodiments shown in FIG. 87.

Referring to FIG. 87, operations to display the graphical screwrepresenting the selected surgical screw as an overlay on both of thefirst and second intra-operative fluoroscopic images, can includedetermining 1300 a trajectory along an axis of the graphical screw anddisplaying a trajectory line that extends from adjacent to a tip of thegraphical screw and along the trajectory to facilitate a user visuallyorienting and positioning the graphical screw relative to a desiredinsertion location on the bone.

Operations to control angular orientation and location of the displayedgraphical screw relative to the bone shown in the first and secondintra-operative fluoroscopic images responsive to receipt of userinputs, can include translating 1302 a location of the displayedgraphical screw responsive to determining that the user has pressed on atouch-sensitive screen of the display device 612 over a screw body ofthe graphical screw while moving location of the user's continuedpressing along the touch-sensitive screen. The operations can furtherinclude angularly pivoting 1304 the displayed graphical screw responsiveto determining that the user has pressed on the touch-sensitive screenover a screw head and/or tip of the graphical screw while movinglocation of the user's continued pressing along the touch-sensitivescreen.

Operations to control angular orientation and location of the displayedgraphical screw relative to the bone shown in the first and secondintra-operative fluoroscopic images responsive to receipt of userinputs, can include selecting 1306 a length of the displayed graphicalscrew from among a set of defined lengths for surgical screws responsiveto determining that the user has pressed on a touch-sensitive screen ofthe display device 612 over a screw tip or a screw head of the graphicalscrew while moving location of the user's continued pressing along thetouch-sensitive screen a measured distance. The selected length isstored 1308 in the surgical plan data structure.

Fluoroscopic Imaging Workflow Navigate Tab

FIG. 76 illustrates the NAVIGATE tab allowing the user to visualize thenavigated instrument trajectory and the planned trajectory with respectto patient anatomy.

The robotic arm precisely aligns the end-effector to the plannedtrajectory. Referring to FIG. 76, select the desired screw label on theright of the screen.

The screw plan is active when the screw label is highlighted and therobotic arm can be moved by the bracelet or pressing the foot pedal. Therobotic arm first moves up in order to clear obstacles in the surgicalfield and then down along the trajectory. Once on the trajectory, therobotic arm can move up/down along the trajectory but does not move offof the trajectory unless the screw plan is deselected.

The real-time instrument/implant trajectory is displayed on the patientimages along with the planned screw, allowing the user to confirm thedesired trajectory. If the real-time trajectory is not acceptable, theuser can return to the PLAN tab to select another trajectory. If thereal-time trajectory is acceptable, the user inserts the screw accordingto the instrument's current trajectory to the desired depth.

GPS instruments are displayed as they are advanced through theend-effector. While navigating the instruments, periodically observe themonitor and surgical site to ensure consistency between tactile andnavigation feedback.

Non-navigated metallic Globus instruments may be used through the guidetube while it is stationary for surgical applications unrelated to screwplacement.

Monitor the surveillance marker during the procedure. If thesurveillance marker indicates significant movement of the DRB, performan anatomical landmark check. If the landmark check is satisfactory,re-register the surveillance marker. If the landmark check fails,re-register the patient.

There are multiple navigation tab icons. Referring to FIG. 76, the forcegauge 761 indicates the force exerted on the end-effector. The image ofthe instrument at the bottom of the force gauge shows the activeinstrument in the end-effector or the end-effector image if noinstrument is inserted. The surveillance marker error gauge 762indicates the distance that the patient reference has moved in relationto the surveillance marker. The full range of the scale is 2 mm. The DRBicon 763 indicates dynamic reference base visibility. If the DRB isvisible by the camera, the background is green. If the DRB is notvisible by the camera, the background is red.

Navigation-Only Procedures

FIG. 77 illustrates how the robotic computer system may be used fornavigation without the robotic arm and end effector. Pre-surgicalplanning is optional. Referring to FIG. 77, all verified GPS instrumentsare visible on loaded patient images when moved within the view of thecamera. The instruments are displayed with respect to the patient.

Refer to the corresponding application and imaging workflow for theimaging modality (pre-operative CT, intra-operative CT, or fluoroscopy).

Use the IMAGE tab to load the desired patient images.

After instrument registration has been completed, a landmark check, orverification, should be performed to ensure that the registration wascalculated successfully. Using the navigated verification probe, touchan anatomical landmark and verify that the corresponding location isshown on the system monitor. Repeat this process using 2-3 landmarks.

Use the PLAN tab to plan screw placement if desired. Select the desiredscrew label on the right of the screen to choose the screw plan.

Use the NAVIGATE tab to display the screw and navigated instrumentsduring the procedure.

Monitor the surveillance marker during the procedure. If thesurveillance marker indicates significant movement of the DRB, performan anatomical landmark check. If the landmark check is satisfactory,re-register the surveillance marker. If the landmark check fails,re-register the patient.

Trajectory-Only Procedures

FIG. 78 illustrates how the robotic computer system may be used fortrajectory guidance using the robotic arm without navigated instruments.Referring to t FIG. 78, the guide tube serves as a rigid retractor thatcan be moved within the surgical field or aligned to a trajectoryautomatically or manually.

Refer to the corresponding application and imaging workflow for theimaging modality (pre-operative CT, intra-operative CT, or fluoroscopy).Use the IMAGE tab to load the desired patient images.

A landmark check, or verification, should be performed to ensure thatthe registration was calculated successfully. Using the navigatedverification probe, touch an anatomical landmark and verify that thecorresponding location is shown on the system monitor. Repeat thisprocess using 2-3 landmarks.

Use the PLAN tab to plan screw placement. Select the desired screw labelon the right of the screen. The screw plan is active when the screwlabel is highlighted and the robotic arm can be moved by the bracelet orby pressing the foot pedal and moving the arm. The robotic arm firstmoves up to clear obstacles in the surgical field and then down alongthe specified trajectory. Once on the trajectory, the robotic arm can bemoved up/down along the trajectory but does not move off of thetrajectory unless the screw is deselected.

If using k-wires, use the cannulated awl to prepare the starting holeand place the k-wire into bone at the desired trajectory through theguide tube. The end effector should be moved away from the trajectory sothe screw can be placed by k-wire guidance (deselect the screw plan).

Perform the surgical procedure using non-navigated metallic surgicalinstruments that fit through the guide tube diameter.

Monitor the surveillance marker during the procedure. If thesurveillance marker indicates significant movement of the DRB, performan anatomical landmark check. If the landmark check is satisfactory,re-register the surveillance marker. If the landmark check fails,re-register the patient.

Fluoroscopic Imaging Workflow Planning Operations

As explained above, the fluoroscopic imaging workflow operations forplanning by the surgical implant planning computer 610 can includedisplaying the graphical screw representing the selected surgical screwas an overlay on both of the first and second intra-operativefluoroscopic images. The operations can determine 1300 a trajectoryalong an axis of the graphical screw and displaying a trajectory linethat extends from adjacent to a tip of the graphical screw and along thetrajectory to facilitate a user visually orienting and positioning thegraphical screw relative to a desired insertion location on the bone.

The operations may further include directly or indirectly, e.g., via thecomputer 522 and/or controller 546, controlling one or more of themotors 550-554 responsive to content of the surgical plan data structureto regulate movement of the robot arm while positioning the end-effector544 relative to a patient. The operations can control (e.g., 1212 inFIG. 86) angular orientation and location of the displayed graphicalscrew responsive to the movement of the robot arm while the end-effector544 is being positioned relative to the patient.

The operations can further include directly or indirectly, e.g., via thecomputer 522 and/or controller 546, controlling the motors 550-554 tomove the end-effector 544 in a direction along a trajectory defined bythe content of the surgical plan data structure. The operations canfurther include controlling (e.g., 1212 in FIG. 86) location of thedisplayed graphical screw responsive to the movement of the end-effector544 along the trajectory.

The operations can further include, while moving the end-effector 544along the trajectory, directly or indirectly controlling the motors550-554 to resist movement of the end-effector 544 in a directionperpendicular to the trajectory until another operation is perform thatcancels an end-effector trajectory constraint mode.

The operations can further include, prior to initiating the end-effectortrajectory constraint mode, directly or indirectly controlling themotors 550-554 to move the end-effector 544 in a direction upward awayfrom the patient and then toward a location along the trajectory, andpreventing initiation of the end-effector trajectory constraint modebefore reaching the location along the trajectory. The operations cancontrol angular orientation and location of the displayed graphicalscrew responsive to the movement of the robot arm away from the patientand then toward the location along the trajectory.

Software Error Messages

The system alerts the operator of errors through pop-up messages. Thefollowing list describes all possible errors and the actions to correctthem.

Message Description Proposed Remedy End Effector The End Effector is notattached to the Ensure that the End Effector is properly Disconnectedrobot arm. attached. Stabilizer Not Down Stabilizers have not beendeployed. Engage stabilizer. Registration Not The patient scan did notpass automatic Complete registration. Completed registration or wasunregistered via the registration view. Registration Not Registrationhas not yet been transferred Transfer registration Transferred from theintra-op CT registration fixture to the Dynamic Reference Base. CameraDisconnected The connection to the camera was Ensure the camera isproperly dropped, most likely as a result of a loose connected. cable.Camera Frame Rate The frame rate of the camera has Too many instrumentsinview of the Dropped dropped below the system's safe limit. camera.Removing instruments will This is usually due to too many trackedincrease the camera frame rate. instruments/objects in the camera'sview. Camera CRC Data from camera is not valid, or there Disconnectcamera from Robotic Base Mismatch has been a camera communicationStation and reconnect. problem. End Effector The End Effector is notcurrently visible Ensure the End Effector Not Visible to the camera.(This will stop or prevent is in view of the camera. motion as the EndEffector fiducials must be visible to move the robot arm.) DRB NotVisible The Dynamic Reference Base is not Ensure the Dynamic ReferenceBase is currently visible to the camera (this will in view of thecamera. stop motion as the Dynamic Reference Base fiducials must bevisible to move the robot arm). E-Stop pressed Someone has physicallypressed the Rotate the E-Stop E-Stop or Emergency Stop button on thebutton to release. Robot Base Station. This stops motion. PIBCommunication Communication to the PIB (Platform Restart the system.Dropped Interface Board) has been lost. This severs communication to therobotic arm, which stops or prevents motion. Surveillance Marker Thesurveillance marker has moved Perform an anatomical landmark check Movedbeyond its safety-critical limit in relation to ensure navigation isstill accurate. to the Dynamic Reference Base. If navigation isinaccurate, either re- register the patient or discontinue use for thatprocedure. Surveillance Marker Not The surveillance marker has eithershifted Perform an anatomical landmark check Visible dramatically ormoved a great distance, to ensure navigation is still accurate. whichcauses the camera to no longer If navigation is inaccurate, either re-see it. register the patient or discontinue use for that procedure.Active Trajectory Not The robotic arm cannot create a table of MoveRobotic Base Station to allow Reachable position points to move to atrajectory, the arm to reach the trajectory. based on the kinematicsequations used. Maximum Trajectory When the robot arm is locked on to aRestart the move. Error Exceeded trajectory, if the actual position ofthe robot arm exceeds a certain distance from the perceived trajectory,this error will occur. Could be related to excessive force on the EndEffector or kinematic sissues. Excessive force on the Excessive forcehas been applied to the Remove the force. End Effector loadcell, over acertain limit (50N or 11 lbs) Excessive Dynamic The Dynamic ReferenceBase position Perform an anatomical landmark check Reference Base hasshifted relatively quickly, without to ensure navigation is stillaccurate. Movement movement of other objects in the view of Ifnavigation is inaccurate, either re- the camera. register the patient ordiscontinue use for that procedure. Move Enabled Press Move enabled ispressed while activating Release the foot pedal or bracelet, then Errortrajectory. Prevents the robot from activate the trajectory. instantlyentering auto-move mode immediately after activating a trajectory. GMASCommunication Communication with the GMAS controller The system shouldautomatically Failure has been lost. This will stop or prevent connect.If not, restart the system. motion as GMAS is no longer receivingupdates from the client about trajectory and camera. Move EnabledTimeout Move enable has been active for longer Release the foot pedal orbracelet, than threshold, 90 seconds or more. This then re-engage thefoot pedal or bracelet. is a failsafe for accidentally leaving the armengaged. Camera Bumped Massive bump to the camera, in which Call TechSupport. the camera is likely to be permanently damaged. This is anerror thrown internally by the NDI software. Tool in End Effector If aninstrument is in the End Effector Remove instrument from End Effector.when attempting to move, motion will be disallowed and this error willbe displayed. Move Enabled Test The move enabled test has failed. Ensureno buttons are pressed on Failure the system and the system willautomatically retry. Motion Homing Failure The homing routine for therobot has Call Tech Support. failed. This causes the robotic arm to loseits relative positions. This test can be retried, but if it consistentlyfails, there are no user actions to fix. Need to Home Robot has not runits homing routine, Call Tech Support. thus the robot arm does not knowits relative positions.

Further Definitions and Embodiments:

In the above-description of various embodiments of the presentdisclosure, aspects of the present disclosure may be illustrated anddescribed herein in any of a number of patentable classes or contextsincluding any new and useful process, machine, manufacture, orcomposition of matter, or any new and useful improvement thereof.Accordingly, aspects of the present disclosure may be implemented inentirely hardware, entirely software (including firmware, residentsoftware, micro-code, etc.) or combining software and hardwareimplementation that may all generally be referred to herein as a“circuit,” “module,” “component,” or “system.” Furthermore, aspects ofthe present disclosure may take the form of a computer program productcomprising one or more computer readable media having computer readableprogram code embodied thereon.

Any combination of one or more computer readable media may be used. Thecomputer readable media may be a computer readable signal medium or acomputer readable storage medium. A computer readable storage medium maybe, for example, but not limited to, an electronic, magnetic, optical,electromagnetic, or semiconductor system, apparatus, or device, or anysuitable combination of the foregoing. More specific examples (anon-exhaustive list) of the computer readable storage medium wouldinclude the following: a portable computer diskette, a hard disk, arandom access memory (RAM), a read-only memory (ROM), an erasableprogrammable read-only memory (EPROM or Flash memory), an appropriateoptical fiber with a repeater, a portable compact disc read-only memory(CD-ROM), an optical storage device, a magnetic storage device, or anysuitable combination of the foregoing. In the context of this document,a computer readable storage medium may be any tangible medium that cancontain, or store a program for use by or in connection with aninstruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device. Program codeembodied on a computer readable signal medium may be transmitted usingany appropriate medium, including but not limited to wireless, wireline,optical fiber cable, RF, etc., or any suitable combination of theforegoing.

Computer program code for carrying out operations for aspects of thepresent disclosure may be written in any combination of one or moreprogramming languages, including an object oriented programming languagesuch as Java, Scala, Smalltalk, Eiffel, JADE, Emerald, C++, C#, VB.NET,Python or the like, conventional procedural programming languages, suchas the “C” programming language, Visual Basic, Fortran 2003, Perl, COBOL2002, PHP, ABAP, dynamic programming languages such as Python, Ruby andGroovy, or other programming languages. The program code may executeentirely on the user's computer, partly on the user's computer, as astand-alone software package, partly on the user's computer and partlyon a remote computer or entirely on the remote computer or server. Inthe latter scenario, the remote computer may be connected to the user'scomputer through any type of network, including a local area network(LAN) or a wide area network (WAN), or the connection may be made to anexternal computer (for example, through the Internet using an InternetService Provider) or in a cloud computing environment or offered as aservice such as a Software as a Service (SaaS).

Aspects of the present disclosure are described herein with reference toflowchart illustrations and/or block diagrams of methods, apparatus(systems), and computer program products according to embodiments of thedisclosure. It will be understood that each block of the flowchartillustrations and/or block diagrams, and combinations of blocks in theflowchart illustrations and/or block diagrams, can be implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable instruction executionapparatus, create a mechanism for implementing the functions/actsspecified in the flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computerreadable medium that when executed can direct a computer, otherprogrammable data processing apparatus, or other devices to function ina particular manner, such that the instructions when stored in thecomputer readable medium produce an article of manufacture includinginstructions which when executed, cause a computer to implement thefunction/act specified in the flowchart and/or block diagram block orblocks. The computer program instructions may also be loaded onto acomputer, other programmable instruction execution apparatus, or otherdevices to cause a series of operational steps to be performed on thecomputer, other programmable apparatuses or other devices to produce acomputer implemented process such that the instructions which execute onthe computer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

It is to be understood that the terminology used herein is for thepurpose of describing particular embodiments only and is not intended tobe limiting of the invention. Unless otherwise defined, all terms(including technical and scientific terms) used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich this disclosure belongs. It will be further understood that terms,such as those defined in commonly used dictionaries, should beinterpreted as having a meaning that is consistent with their meaning inthe context of this specification and the relevant art and will not beinterpreted in an idealized or overly formal sense unless expressly sodefined herein.

The flowchart and block diagrams in the figures illustrate thearchitecture, functionality, and operation of possible implementationsof systems, methods, and computer program products according to variousaspects of the present disclosure. In this regard, each block in theflowchart or block diagrams may represent a module, segment, or portionof code, which comprises one or more executable instructions forimplementing the specified logical function(s). It should also be notedthat, in some alternative implementations, the functions noted in theblock may occur out of the order noted in the figures. For example, twoblocks shown in succession may, in fact, be executed substantiallyconcurrently, or the blocks may sometimes be executed in the reverseorder, depending upon the functionality involved. It will also be notedthat each block of the block diagrams and/or flowchart illustration, andcombinations of blocks in the block diagrams and/or flowchartillustration, can be implemented by special purpose hardware-basedsystems that perform the specified functions or acts, or combinations ofspecial purpose hardware and computer instructions.

The terminology used herein is for the purpose of describing particularaspects only and is not intended to be limiting of the disclosure. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. Like reference numbers signify like elements throughoutthe description of the figures.

The corresponding structures, materials, acts, and equivalents of anymeans or step plus function elements in the claims below are intended toinclude any disclosed structure, material, or act for performing thefunction in combination with other claimed elements as specificallyclaimed. The description of the present disclosure has been presentedfor purposes of illustration and description, but is not intended to beexhaustive or limited to the disclosure in the form disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of thedisclosure. The aspects of the disclosure herein were chosen anddescribed in order to best explain the principles of the disclosure andthe practical application, and to enable others of ordinary skill in theart to understand the disclosure with various modifications as aresuited to the particular use contemplated.

What is claimed is:
 1. A surgical implant planning computer comprising:at least one network interface connectable to a fluoroscopy imager, amarker tracking camera, and a robot having a robot base coupled to arobot arm that is movable by motors relative to the robot base; adisplay device; at least one processor; and at least one memory storingprogram code that is executed by the at least one processor to performoperations comprising: performing a registration setup mode comprisingdetermining occurrence of a first condition indicating that the markertracking camera can track markers that are on a registration fixture ofthe fluoroscopy imager, and determining occurrence of a second conditionindicating that the marker tracking camera can track dynamic referencebase markers attached to an end-effector attached to the robot arm;while both of the first and second conditions are determined to continueto occur receiving and storing in the memory a first intra-operativefluoroscopic image of a patient along a first plane and a secondintra-operative fluoroscopic image of the patient along a second planethat is orthogonal to the first plane; displaying the stored first andsecond intra-operative fluoroscopic images on the display device;receiving a user's selection of a surgical implant from a set of definedsurgical implants; displaying a graphical implant representing theselected surgical implant as an overlay on both of the displayed firstand second intra-operative fluoroscopic images; wherein the operationsfurther comprise: controlling the motors responsive to content of thesurgical plan data structure to regulate movement of the robot arm whilepositioning the end-effector relative to a patient; and controllingangular orientation and location of the displayed graphical screwresponsive to the movement of the robot arm while the end-effector ispositioned relative to the patient.
 2. The surgical implant planningcomputer of claim 1, further including controlling angular orientationand location of the displayed graphical implant relative to anatomyshown in the first and second intra-operative fluoroscopic images; andstoring an indication of an angular orientation and a location of thedisplayed graphical implant in a surgical plan data structure responsiveto receipt of a defined user input.
 3. The surgical implant planningcomputer of claim 2, wherein the operations to display the graphicalimplant representing the selected surgical implant as an overlay on bothof the first and second intra-operative fluoroscopic images, comprise:determining a trajectory along an axis of the graphical implant; anddisplaying a trajectory line that extends from adjacent to a first endof the graphical implant and along the trajectory to facilitate a uservisually orienting and positioning the graphical implant relative to adesired insertion location on the bone.
 4. The surgical implant planningcomputer of claim 3, wherein the operations to control angularorientation and location of the displayed graphical implant relative tothe bone shown in the first and second intra-operative fluoroscopicimages responsive to receipt of user inputs, comprise: translating alocation of the displayed graphical implant responsive to determiningthat the user has pressed on a touch-sensitive screen of the displaydevice over a graphical implant while moving location of the user'scontinued pressing along the touch-sensitive screen; and angularlypivoting the displayed graphical implant responsive to determining thatthe user has pressed on the touch-sensitive screen over a portion of thegraphical implant while moving location of the user's continued pressingalong the touch-sensitive screen.
 5. The surgical implant planningcomputer of claim 3, wherein the operations to control angularorientation and location of the displayed graphical implant relative tothe bone shown in the first and second intra-operative fluoroscopicimages responsive to receipt of user inputs, comprise: selecting alength of the displayed graphical screw from among a set of definedlengths for surgical screws responsive to determining that the user haspressed on a touch-sensitive screen of the display device over a screwtip or a screw head of the graphical screw while moving location of theuser's continued pressing along the touch-sensitive screen a measureddistance, wherein the selected length is stored in the surgical plandata structure.
 6. The surgical implant planning computer of claim 1,wherein the operations further comprise: controlling the motors to movethe end-effector in a direction along a trajectory defined by thecontent of the surgical plan data structure; and controlling location ofthe displayed graphical screw responsive to the movement of theend-effector along the trajectory.
 7. The surgical implant planningcomputer of claim 1, wherein the operations further comprise: whilemoving the end-effector along the trajectory, further controlling themotors to resist movement of the end-effector in a directionperpendicular to the trajectory until another operation is perform thatcancels an end-effector trajectory constraint mode.
 8. The surgicalimplant planning computer of claim 7, wherein the operations furthercomprise: prior to initiating the end-effector trajectory constraintmode, controlling the motors to move the end-effector in a directionupward away from the patient and then toward a location along thetrajectory; preventing initiation of the end-effector trajectoryconstraint mode before reaching the location along the trajectory; andcontrolling angular orientation and location of the displayed graphicalscrew responsive to the movement of the robot arm away from the patientand then toward the location along the trajectory.
 9. A method by asurgical implant planning computer, the method comprising: performing aregistration setup mode comprising determining occurrence of a firstcondition indicating that a marker tracking camera can track markersthat are on a fluoroscopy registration fixture of the fluoroscopyimager, and determining occurrence of a second condition indicating thatthe marker tracking camera can track dynamic reference base markersattached to a robot arm of a robot and/or an end-effector connected tothe robot arm; while both of the first and second conditions aredetermined to continue to occur, receiving and storing in a memory afirst intra-operative fluoroscopic image of a patient along a firstplane and to obtain a second intra-operative fluoroscopic image of thepatient along a second plane that is orthogonal to the first plane;displaying the stored first and second intra-operative fluoroscopicimages on a display device; receiving a user's selection of a surgicalimplant from a set of defined surgical implants; displaying a graphicalimplant representing the selected surgical implant as an overlay on bothof the displayed first and second intra-operative fluoroscopic images;and controlling angular orientation and location of the displayedgraphical implant relative to a bone shown in the first and secondintra-operative fluoroscopic images responsive to receipt of userinputs; controlling motors responsive to content of the surgical plandata structure to regulate movement of the robot arm while positioningthe end-effector relative to a patient; and controlling angularorientation and location of the displayed graphical implant responsiveto the movement of the robot arm while the end-effector is positionedrelative to the patient.
 10. The method of claim 9, wherein the methodfurther includes the step of storing an indication of an angularorientation and a location of the displayed graphical screw in asurgical plan data structure responsive to receipt of a defined userinput.
 11. The method of claim 9, wherein displaying the graphicalimplant representing the selected surgical implant as an overlay on bothof the first and second intra-operative fluoroscopic images, comprises:determining a trajectory along an axis of the graphical implant; anddisplaying a trajectory line that extends from adjacent to a tip of thegraphical implant and along the trajectory to facilitate a user visuallyorienting and positioning the graphical implant relative to a desiredinsertion location.
 12. The method of claim 11, wherein controllingangular orientation and location of the displayed graphical implantrelative to an anatomy shown in the first and second intra-operativefluoroscopic images responsive to receipt of user inputs, comprises:translating a location of the displayed graphical implant responsive todetermining that the user has pressed on a touch-sensitive screen of thedisplay device over an implant body of the graphical implant whilemoving location of the user's continued pressing along thetouch-sensitive screen; and angularly pivoting the displayed graphicalimplant responsive to determining that the user has pressed on thetouch-sensitive screen over the graphical implant while moving locationof the user's continued pressing along the touch-sensitive screen. 13.The method of claim 12, wherein controlling angular orientation andlocation of the displayed graphical implant relative to the bone shownin the first and second intra-operative fluoroscopic images responsiveto receipt of user inputs, comprises: selecting a length of thedisplayed graphical implant from among a set of defined lengths forsurgical implant responsive to determining that the user has pressed ona touch-sensitive screen of the display device over graphical implantwhile moving location of the user's continued pressing along thetouch-sensitive screen a measured distance, wherein the selected lengthis stored in the surgical plan data structure.
 14. The method of claim9, further comprising: controlling the motors to move the end-effectorin a direction along a trajectory defined by the content of the surgicalplan data structure; and controlling location of the displayed graphicalimplant responsive to the movement of the end-effector along thetrajectory.
 15. The method of claim 9, further comprising: while movingthe end-effector along the trajectory, further controlling the motors toresist movement of the end-effector in a direction perpendicular to thetrajectory until another operation is perform that cancels anend-effector trajectory constraint mode.
 16. The method of claim 15,further comprising: prior to initiating the end-effector trajectoryconstraint mode, controlling the motors to move the end-effector in adirection upward away from the patient and then toward a location alongthe trajectory; preventing initiation of the end-effector trajectoryconstraint mode before reaching the location along the trajectory; andcontrolling angular orientation and location of the displayed graphicalimplant responsive to the movement of the robot arm away from thepatient and then toward the location along the trajectory.
 17. Acomputer program product for a surgical implant planning computer, thecomputer program product comprising: a non-transitory computer readablemedium storing program code that is executable by at least one processorof the surgical implant planning computer to perform operationscomprising: performing a registration setup mode comprising determiningoccurrence of a first condition indicating that a marker tracking cameracan track reflective markers that are on a fluoroscopy registrationfixture of the fluoroscopy imager, and determining occurrence of asecond condition indicating that the marker tracking camera can observeto track dynamic reference base markers attached to a robot arm or anend-effector attached to the robot arm; while both of the first andsecond conditions are determined to continue to occur, allowingoperations to be performed to obtain a first intra-operativefluoroscopic image of a patient along a first plane and to obtain asecond intra-operative fluoroscopic image of the patient along a secondplane that is orthogonal to the first plane; displaying the first andsecond intra-operative fluoroscopic images on a display device;receiving a user's selection of a surgical implant from a set of definedsurgical implants; displaying a graphical implant representing theselected surgical implant as an overlay on both of the displayed firstand second intra-operative fluoroscopic images; determining a trajectoryalong an axis of the graphical implant; and displaying a trajectory linethat extends from adjacent to a first end of the graphical implant andalong the trajectory to facilitate a user visually orienting andpositioning the graphical implant relative to a desired insertionlocation on the bone; controlling motors responsive to content of thesurgical plan data structure to regulate movement of the robot arm whilepositioning the end-effector relative to a patient; and controllingangular orientation and location of the displayed graphical implantresponsive to the movement of the robot arm while the end-effector ispositioned relative to the patient.
 18. The computer program product ofclaim 17, further including controlling angular orientation and locationof the displayed graphical implant relative to an anatomical part of apatient shown in the first and second intra-operative fluoroscopicimages responsive to receipt of user inputs; and storing an indicationof an angular orientation and a location of the displayed graphicalimplant in a surgical plan data structure responsive to receipt of adefined user input.